Dutasteride and Tamsulosin Hydrochloride Capsules

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Dutasteride and Tamsulosin Hydrochloride Capsules contain NLT 90.0% and NMT 110.0% of the labeled amount of Dutasteride (C₂₇H₃₀F₆N₂O₂) and NLT 90,0% and NMT 110.0% of the labeled amount of tamsulosin hydrochloride (C₂₀H₂₈N₂O₅S · HCl). They may contain butylated hydroxytoluene or another suitable antioxidant.

2 IDENTIFICATION

A. The retention time of the dutasteride peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay,

Procedure 1: Dutasteride.

B. The UV spectrum of the dutasteride peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay,

Procedure 1: Dutasteride.

C. The retention time of the tamsulosin peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay,

Procedure 2: Tamsulosin Hydrochloride

D. The UV spectrum of the tamsulosin peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay,

Procedure 2: Tamsulosin Hydrochloride

3 ASSAY

PROCEDURE 1: DUTASTERIDE

Buffer: 1.37 g/L of potassium dihydrogen phosphate in water. Adjust with phosphoric acid to a pH of 3.0.

Mobile phase: Acetonitrile and Buffer (65:35)

Diluent A: Acetonitrile and water (90:10)

Diluent B: Acetonitrile and water (50:50)

Standard solution: 0.02 mg/mL of USP Dutasteride RS in Diluent A. Sonicate to dissolve, if necessary.

Sample solution: Nominally 0.02 mg/mL of dutasteride prepared as follows. Take Capsules (NLT 20) and remove the contents, separating the pellets and the soft gelatin capsules. Weigh and transfer the intact soft gelatin capsules into a 500-ml volumetric flask. Add Diluent B to 20% of the total volume, and sonicate with shaking until the capsules completely rupture. Add acetonitrile to 50% of the total volume and sonicate for NLT 10 min with shaking at every 3 min for a period of 30 s. Dilute with acetonitrile to volume and mix. Pass the solution through a suitable filter of 0.22-pm pore size. Discard the first few milliliters of the filtrate.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 280 nm. For Identification B, use a diode array detector in the range of 200-400 nm.

Column: 4.6-mm 15-cm; 5-um packing 11

Flow rate: 2 mL/min

Injection volume: 100 µL

Run time: NLT 2.5 times the retention time of dutasteride

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of dutasteride (C₂₇H₃₀F₆N₂O₂) in the portion of Capsules taken:

Result = (r_U/(r_S) × (C_S /C_U) × 100

r_U = peak response of dutasteride from the Sample solution

r_S = peak response of dutasteride from the Standard solution

C_S = concentration of USP Dutasteride RS in the Standard solution (mg/mL)

C_U =  nominal concentration of dutasteride in the Sample solution (mg/ml.)

Acceptance criteria: 90.0%-110.0%

PROCEDURE 2: TAMSULOSIN HYDROCHLORIDE

Buffer: 2.554 g/L of anhydrous disodium hydrogen phosphate and 0.272 g/l. of potassium dihydrogen phosphate in water. Adjust with dilute phosphoric acid to a pH of 7.0.

Mobile phase: Methanol and Buffer (55:45)

Standard stock solution: 160 µg/mL of USP Tamsulosin Hydrochloride RS in methanol. Sonicate to dissolve, if necessary.

Standard solution: 8 µg/mL of USP Tamsulosin Hydrochloride RS from Standard stock solution in Mobile phase

Sample solution: Nominally 8 µg/ml. of tamsulosin hydrochloride prepared as follows. Weigh Capsules (NLT 20) and determine the average net content. Open the capsules and remove pellets, and determine weight of the capsules with the soft gelatin capsules. Calculate the average net content of pellets. Accurately weigh and transfer a quantity of pellets equivalent to about 2 mg of tamsulosin hydrochloride to a 250-ml volumetric flask. Add 1 N sodium hydroxide solution to 12% of the total volume and sonicate for NLT 30 min. Add methanol to 28% of the total volume and sonicate for NLT 15 min. Dilute with Mobile phase to volume and mix. Pass a portion of the solution through a suitable filter of 0.45 µm pore size, Discard the first few milliliters of the filtrate.

Chromatographic system

(See Chromatography (621) System Suitability)

Mode: LC

Detector: UV 225 nm. For Identification D, use a diode array detector in the range of 200-400 nm.

Column: 4.6-mm x 25-cm; 5-um packing L1

Column temperature: 35"

Flow rate: 1 mL/min

Injection volume: 50 µl.

Run time: NLT 1.5 times the retention time of tamsulosin

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of tamsulosin hydrochloride (C₂₀H₂₈N₂O₅S · HCl) in the portion of Capsules taken:

Result = (r_U/(r_S) × (C_S /C_U) x 100

r_U = peak response of tamsulosin from the Sample solution

r_S = peak response of tamsulosin from the Standard solution

C_S = concentration of USP Tamsulosin Hydrochloride RS in the Standard solution (µg/mL) 

C_U = nominal concentration of tamsulosin in the Sample solution (µg/mL)

Acceptance criteria: 90.0%-110.0%

4 OTHER COMPONENTS

CONTENT OF BUTYLATED HYDROXYTOLJENE (IF PRESENT IN THE PRODUCT)

Buffer, Mobile phase, and Diluent A: Prepare as directed in the Assay, Procedure 1: Dutasteride

Standard solution: 7 pg/ml of USP Butylated Hydroxytoluene RS in Diluent A. Sonicate to dissolve.

Sample solution: Nominally 7 µg/ml of butylated hydroxytoluene in Diluent A prepared as follows. Remove the contents of the Capsules (NLT 20) separating the pellets and soft gelatin capsules, Remove as completely as possible the content of the soft gelatin capsules. Mix the contents, and determine the average net content of the soft gelatin capsules. Accurately weigh and transfer a quantity of the contents of the soft gelatin capsules equivalent to about 0.175 mg of butylated hydroxytoluene to a 25-ml volumetric flask. Add Diluent A to 60% of the total volume and sonicate to dissolve. Dilute with Diluent A to volume and mix.

Chromatographic system: Proceed as directed in the Assay, Procedure 1: Dutasteride, except for Injection volume.

Injection volume: 50 µL

System suitability

Sample: Standard solution

Suitability requirements.

Tailing factor: NMT 2.0

Relative standard deviation: NMT 5.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of butylated hydroxytoluene (CHO) in the portion of Capsules taken

Result = (r_U/(r_S) × (C_S /C_U) × 100

r_U = peak response of butylated hydroxytoluene from the Sample solution

r_S = peak response of butylated hydroxytoluene from the Standard solution

C_S =concentration of LISP Butylated Hydroxytoluene RS in the Standard solution (ug/ml.)

C_U = nominal concentration of butylated hydroxytoluene in the Sample solution (µg/mL)

Acceptance criteria: 85.0%-110.0% of the labeled amount of butylated hydroxytoluene (CHO)

5 PERFORMANCE TESTS

Change to read:

DISSOLUTION (711)

Test 1 (RB May 2024)

Test for dutasteride

Tier 1

Medium: 10 g/L of cetyltrimethylammonium bromide in 0.1 N hydrochloric acid: 900 mL

Apparatus 2: 75 rpm with a suitable sinker

Time: 45 min

Tier 2

Medium: Dissolve 10 g of cetyltrimethylammonium bromide and 1.6 g of pepsin. purified in 1000 mL of 0.1 N hydrochloric acid: 900 ml.

Apparatus 2: 75 rpm with a suitable sinker

Time: 45 min

Buffer and Mobile phase: Prepare as directed in the Assay, Procedure 1. Dutasteride,

Standard stock solution: 0.22 mg/ml of USP Dutasteride RS in methanol. Sonicate to dissolve

Standard solution: 0.55 µg/mL of USP Dutasteride RS from Standard stock solution in Medium

Sample solution: Withdraw and pass about 10 mL of the solution under test through a suitable filter of 0.45-um pore size, discarding the first few milliliters of the filtrate.

Dissolution procedure: Perform the test using the conditions under Tier 1. In the presence of cross-linking repeat the test with new Capsules using the conditions under Tier 2

Detector: UV 240 nm

Chromatographic system: Proceed as directed in the Assay, Procedure 1: Dutasteride except for Detector and Injection volume

Injection volume: 500 µl.

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of dutasteride (CHF NO) dissolved

Result = (r_U/(r_S) × C_S  x V x (1/L) x 100

r_U = peak response of dutasteride from the Sample solution

r_S =peak response of dutasteride from the Standard solution

C_S = concentration of USP Dutasteride RS in the Standard solution (mg/ml)

V = volume of Medium, 900 mL

L = label claim (mg/Capsule)

Tolerances: NLT 80% (Q) of the labeled amount dutasteride (C₂₇H₃₀F₆N₂O₂) is dissolved.

Test for tamsulosin hydrochloride

Acid stage medium: 0.1 N bydrochloric acid 750 mL

Buffer stage medium: Sodium phosphate buffer, pH 6.8 (after 2 h, add 250 ml of 76 g/L sodium phosphate tribasic previously heated to 37±0.5°, to the Acid stage medium and adjust with either a dilute phosphoric acid or dilute sodium hydroxide solution to a pH of 6.8.1 0.1); 1000 mL

Apparatus 2:50 rpm with a suitable sinker

Times: 2 h in Acid stage medium; 3 and 7 h in Buffer stage medium. The time in the Buffer stage medium includes the time in the Acid stage medium

Buffer: Dissolve 6.8 g of ammonium phosphate, dibasic in about 800 mL of water, add 2.0 mL of triethylamine, and adjust with phosphoric acid to a pH of 7.0. Dilute with water to 1000 ml.

Mobile phase: Acetonitrile and Buffer (30:70)

Standard stock solution: 0.4 mg/ml of USP Tamsulosin Hydrochloride RS in methanol. Sonicate to dissolve, if necessary

Acid stage standard solution: 0.5 µg/ml of USP Tamsulosin Hydrochloride BS from Standard stock solution in Acid stage medium

Buffer stage standard solution: 0.4 µg/ml, of USP Tamsulosin Hydrochloride RS from Standard stock solution in Buffer stage medium

Acid stage sample solution: Withdraw and pass about 10 mL of the solution under test through a suitable filter of 0.45-µm pore size Discard the first few milliliters of the filtrate. Replace the portion removed with the same volume of Acid stage medium

Buffer stage sample solution: At the specified time points, withdraw and pass about 10 ml of the solution under test through a suitable filter of 0.45-um pore size. Discard the first few milliliters of the filtrate. Replace the portion removed at each time point with the same volume of Buffer stage medlum.

Chromatographic system

(See Chromatography (621) System Suitability)

Mode: LC

Detector: UV 225 nm

Column: 4.6-mm x 15 cm; 5 μm packing L

Column temperature: 30°

Flow rate: 1 mL/min

Injection volume: 250 µL

Run time: NLT 1.5 times the retention time of tamsulosin

System suitability

Sample: Buffer stage standard solution

Sultability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 5.0%

Analysis

Calculate the concentration (C_i) of tamsulosin hydrochloride (C₂₀H₂₈N₂O₅S · HCl) in the sample withdrawn from the vessel at

Samples: Acid stage standard solution, Buffer stage standard solution, Acid stage sample solution, and Buffer stage sample solution

each time point (1) as shown in Table 1:

C_i =(r_u/r_s) x C_s

r_U = peak response of tamsulosin from the Acid stage sample solution or Buffer stage sample solution

r_S =peak response of tamsulosin from the Acid stage standard solution or Buffer stage standard solution

C_S = concentration of USP Tamsulosin Hydrochloride RS in the Acid stage standard solution or Buffer stage standard solution (mg/mL)

Calculate the percentage of the labeled amount of tamsulosin hydrochloride (CHNOS HCI) dissolved at each time point (1) as shown in Table

Result₁ = (C₁xV₁) x (1/L) × 100

Result₂ = (C₂xV₂) + (C₁xV_s) × (1/L) × 100

Result₃ = ((C₃xV₂) + [(C₂xC₁) x V_s]} x (1/L) × 100

Ci concentration of tamsulosin in the portion of sample withdrawn at each time point (i) (mg/mL)

V₁ = volume of the Acid stage medium, 750 mL

L = label claim (mg/Capsule)

V₂ = volume of the Buffer stage medium, 1000 ml

V₃ = volume of the Acid stage sample solution or Buffer stage sample solution withdrawn at each time point and replaced with Acid stage medium or Buffer stage medium (mL)

Tolerances: See Table 1

The percentages of the labeled amount of tamsulosin hydrochloride (CH, NOS HCI) dissolved at the times specified conform to Dresolution (7111, Acceptance Table 2

Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Test for dutasteride

Tier 1

Medium: Dissolve 10 g of cetyltomethylammonium bromide in 1 L of 0.1 N hydrochloric acid: 900 ml. Deaeration, if necessary, is carried out prior to adding cetyltrimethylammonium bromide

Apparatus 2: 75 rpm with a suitable sinker

Time: 45 min

Tier 2

Medium: Dissolve 10 g of cetyltrimethylammonium bromide in 1 L of 0.1 N hydrochloric acid. Add 1.6 g of geesin, purified: 900 mL Deaeration, if necessary, is carried out prior to adding cetyltrimethylammonium bromide

Apparatus 2: 75 rpm with a suitable sinker

Time: 45 min

Solution A: Dissolve 1.38 g of sodium phosphate, monobasic in 1000 ml of water, Adjust with phosphoric acid to a pH of 3.0.

Solution B: Acetonitrile

Mobile phase: See Table 2.

Standard stock solution: 0.056 mg/ml of USP Dutasteride RS prepared as follows. Transfer a quantity of USP Dutasteride RS to an appropriate volumetric flask, add 4% of the flask volume of acetonitrile. Sonicate to dissolve, if necessary. Dilute with the corresponding Medium to volume.

Standard solution: 0.00056 mg/ml of USP Dutasteride RS from the Standard stock solution in the corresponding Medium

Sample solution: Pass the solution under test through a suitable filter of 2.7 um pore size, discarding an appropriate volume of filtrate so that a consistent result can be obtained

Dissolution procedure: If results under the conditions of Tier 1 do not meet specifications due to cross-linking, proceed with testing new Capsules under the conditions of Ther 2

Chromatographic system

(See Chromatography (6211 System Suitabrate)

Mode: LC

Detector: UV 225 nm

Column: 4.6-mm x 15-cm, 5-um packing L1

Column temperature: 30°

Flow rate: 1.5 mL/min

Injection volume: 200 µl.

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of dutasteride (CHF,N,O, dissolved:

Result = (r_U/(r_S) × C_S  x V x (1/L) x 100

r_U = peak response of dutasteride from the Sample solution

r_S =peak response of dutasteride from the Standard solution

C_S = concentration of USP Dutasteride RS in the Standard solution (mg/ml)

V = volume of Medium, 900 mL

L = label claim of dutasteride (mg/Capsule)

Tolerances: NLT 80% (0) of the labeled amount of dutasteride (C₂₇H₃₀F₆N₂O₂) is dissolved

Test for tamsulosin hydrochloride

Acid stage medium: 0.1 N hydrochloric acid, 750 mL, deserated, if necessary

Buffer stage medium: 0.05 M sodium phosphate buffer, pH 6.8 (Dissolve 7.1 g of sodium phosphate, dibasic anhydrous and 4.5 mil of 5 N hydrochloric acid in 1 L of water Adjust with andiam hydroxide solution or bydrochloric acid to a pH of 6.8.); 1000 ml, deaerated, if necessary

Apparatus 2: 50 rpm

Time

Acid stage: 2 h

Buffer stage: 2.5 and 5 h. The times in the Buffer stage medium include the time in the Acid stage medium

Solution A, Solution B, and Chromatographic systems: Proceed as directed in the Test for dutasteride

Mobile phase: See Table 3

Standard stock solution: 0.4 mg/mL of USP Tamsulosin Hydrochloride RS prepared as follows. Transfer a quantity of USP Tamsulosin Hydrochloride RS to an appropriate volumetric flask, and add 20% of the flask volume of methanol. Sonicate to dissolve, if necessary Dilute with water to volume

Standard solution: 0.0004 mg/ml, of US Tamsulosin Hydrochloride RS from the Standard stock solution in Buffer stage medium

Acid stage sample solution: Withdraw a suitable volume of the solution under test and pass through a suitable filter of 2.7 jum pore size, discarding an appropriate volume of filtrate so that a consistent result can be obtained.

Buffer stage sample solution: After the Acid stage, carefully remove the Acid stage medium from the vessels, avoiding the loss of test samples, and replace with Buffer stage medium. At the specified time points, withdraw a suitable volume of the solution under test. Pass through a suitable filter of 2.7-um pore size, discarding an appropriate volume of filtrate so that a consistent result can be obtained.

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 50%

Analysin

Samples: Standard solution, Aold stage sample solution, and Buffer stage sample solution

Calculate the percentage (0) of the labeled amount of tamsutusin hydrochloride (CHNOS HCI) dissolved in the Acid stage:

Result = (r_U/(r_S) × C_S  x V_A x (1/L) x 100

r_U = peak response of tamsulosin from the Acid stage sample solution

r_S = peak response of tamsulosin from the Standard solution

C_S = concentration of USP Tamsulosin Hydrochloride RS in the Standard solution (µg/mL) 

V_A = volume of the Acid stage medium, 750 mL

L = label claim of tamsulosin hydrochloride (mg/Capsula

Calculate the concentration (C) of tamsulosan hydrochlorate (C₂₀H₂₈N₂O₅S · HCl) on the sample withdrawn from the vessel at each time point (1) during the Buffer stage:

C_i =(r_u/r_s) x C_s

r_U = peak moponse of tamsulosin from the Buffer stage sample solution

r_S = peak response of tamsulosin from the Standard solution

C_S = concentration of USP Tamaulicen nydrochloride RS in the Standard solution (mg/m)

Calculate the percentage of the labeled amount of tamsulosin hydrochloride(C₂₀H₂₈N₂O₅S · HCl) dissolved at rach time point (i) during the Buffer stage

Result = [(C₁ x V_B) x (1/L) x 100] + Q_A

Result = ({[C₂ x (V_B - V_S)] + (C₁ x V_S)} x (1/L) x 100) + Q_A

Ci = concentration of tamsulosin hydrochloride in the portion of sample withdrawn at each time point during the Buffer stage (mg/ml)

V_B = volume of the Buffe stage medium, 1000 m

L = label claim of tamsulosin hydrochloride (mg/Capsule)

V_S = volume of the Buffer stage samspile solution withdrawn at sach time point during the Buffer stage

Tolerances: See Talble 4

The percentages of the labeled amount of tamsulosin hydrochlonde (CHNOS HC dissolved at the times specified conform so

Graaolution (711). Accentance Table 2

Uweety пе Поми Инта/503 Мeet the requirements for both dutasteride and tamsulosin hydrochloride

6 IMPURITIES

Change to reast

OKANI SUPORTI PROCURE 1: D

Solution A: 137 g/l of drogam phooptate in Adjust with houphooc acid to a pe of 20

Solution B: Acetonitrile and water (90:10)

Mobile phase: See

System suitability stock solution: 0.07 mg/mL of USE Dedrodutaatende RS in methane Sonicate to dissolve.

System suitability solution: 0.7 mg/ml of USP Dutasteride Bli and 7 g/ml, of LSP Dihydrodataciele RS prepared as follows. Transfer a quantity of USP Dutasteride it to a 50ml, volumetric flask. Add Solution 8 to 50% of the total volume and sonicate to dissolve. Add 50m of the System soltabally stock solution, dilute with Solution 8 to volume, and mis

Standard solution: 7 pg/ml of USP Dutasteride RS in Solution B. Sonitate to dissolve, if necessary

Sensitivity solution: 0.35 µg/mL of LISP Dutasteride RS from Standard solution in Solution

Sample solution: Nominally 0.7 mg/ml of dutasteride prepared as follows. Take Capsules (NLT 20) and remove the continta, separating the pelats and the soft gelatin capsules. Accurately weigh the soft gelatin capsules, and remove the content as completely as possibile. Mis and determine the average net content of the soft gelatin capsulas. Accuratify weigh and transfer a quantity of the contents of the soft gelatin capsules equivalent to about 7 mg of dutasteride to a 10-mL volumetric flask. Add Solution & to volume, and mix by shaking.

Chromatographic system (See Cheumatomate 1821). System Suttability)

Mode: LC

Detector: UV 250 nm

Culumen 4.5-25-cm. 5-sam packing

Column temperature: 50

Flew rate: 1 mL/min

Injection volume: 20

System suitability

OFFIC

Samples: System suitability solution, Standard sciution, and Senalivity slution

Suitability requirements

Resolution: NLT 2.0 between dutasteride and dihydrodutastende, System suitability solution

Relative standard deviation: NT 5.0, Standard solution

Signal-to-noise ratioc NLT 10. Sensitivity solution

Analysis

Samples: Standard solution and Sample solution

Calcalate the percentage of each individual unspecified degradation product in the portion of Capsules taken

Result = (r_U/(r_S) × (C_S /C_U) x 100

r_U = peak response of each individual unspecified degradation product from the Sample solution

r_S = peak response of dutasteride hom the Standard solution

C_S = concentration of USB Dutasteride RS in the Standard solution (μg/mL)

C_U = nominal concentration of dutasteride in the Sample solution (μg/mL)

Acceptance criteria: The reporting threshold is 0.05%

Any unspecified degradation product: NMT 10%

Total degradation products: NMT 1.5%

Change to read

O IMPURI, P 2: TH

Buffer A: 2.554 g/L of sodium phosphate, dibasic, anhydrous, 0.272 g/L of potassium phosphate, monobasic, and 2.0 g/L of sodium 1- decanesulfonate in water. Adjust with a dilute phosphoric acid solution to a pH of 7.0.

Buffer B: 2.554 g/L of sodium phosphate, dibasic, anhydrous and 0.272 g/L of potassium phosphate, monobasic in water. Adjust with a dilute phosphoric acid solution to a pH of 7.0.

Solution A: Mettranol, postonitric, and Buffer A (30:20:50)

Solution B: Acetonitrile and water (00:40)

Mobile phase: See

Diluent: Methanci and truffer & (55:45)

Standard solution: 0.2 µg/ml of SP Trasa Hydrochloride 15 in Went Sonicate to dissolve, if necessary

Sensitivity solution: 0.05 µg/mt of USP Tamsulosin Hydrachiande RS from Standard solution in Diluent

Sample solution: Nominally 0.3 mg/ml of tamsulosin hydrochloride prepared as follows. Determine the weight of Capsules (NLT 20. Open the capsules and remove the pellets. Determine the weight of the Capsules with the soft gelatin capsules, and calculate the average net condent of the pellets. Accurately weigh and transfer a quantity of periferts equivalent to 10 mg of tamsulusin hydrochloride to a 100-volumenne flask, add 0.5 N sodium hydroxide solution to 25% of the total vorume, and somcate for NLT 30 min. Add Diluent to 30% of the Sotal volume and shake by mechanical means for about 30 min. Dikte with Diluent to volume and mix. Paus a portion of the solution through a suitable fiter of 0.45-gm pore size. Discard the first few mililiters of the fitrate

Chromatographic system

Mode: LC

Detector: UV 225 mm

Column: 4.1mmx25-cm; 5-um packing

OFF

Column temperature 36

Flow rate: 1 mL/min

Injection volume: 100 μ

System suitability

Samples: Standard sofution and Sensitivty solution

Suitability requirements

Relative standard deviation: NMT 100%, Standard solution

Signal-to-noise ratioc NLT 10. Sensitivity solution

Analysis

Samples: Stamtavou and Sample auton

Calculate the percentage of each individual unspecified degradation product in the portion of Capsules taken:

Result = (r_U/(r_S) × (C_S /C_U) x 100

r_U = esponse of each individual umpecified degradation product from the Samanle solution

r_S = peak response of tamsulosin hom the Standard solution

C_S = concentration of LSP Tamsulosin Hydrushdunde RS in the Standard salution (μg/mL)

C_U = nominal concentration of tamsulosin in the Sample solution (μg/mL)

Acceptance criteria: The reporting threshold is 0.05%

Any unspecified degradation product: NMT 1.0%

Total degradation jeoducts: NMTLES

7 ADDITIONAL REQUIREMENTS

Packaging and Storage: Store at controlled room temperature

Add the following

Labeling: The labeling states the Dissolution test used only if Test 1 is not used