Nevirapine Tablets

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

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

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1 DEFINITION

Nevirapine Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of nevirapine (C₁₅H₁₄N₄O).

2 IDENTIFICATION

Change to read:

A. ^▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K _{▲(CN 1-MAY-2020)}

Sample: Transfer a portion of powdered Tablets equivalent to 25 mg of nevirapine to a 50-mL volumetric flask. Dissolve in 10 mL of methylene chloride. Swirl the solution for 30-60 s, and pass through a medium sintered-glass, fritted vacuum funnel. Using a glass syringe, pass the filtrate through a Teflon filter of 0.45-µm pore size. Dry the extract at 105° for a minimum of 1 h.

Acceptance criteria: Meet the requirements

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

3 ASSAY

PROCEDURE

Mobile phase: Acetonitrile and water (23:77)

Diluent: Dehydrated alcohol and water (1:1)

System suitability solution: 0.025 mg/mL of USP Nevirapine Anhydrous RS and 0.025 mg/mL of USP Nevirapine Related Compound A RS in Diluent

Standard solution: 0.025 mg/mL. of USP Nevirapine Anhydrous RS in Diluent

Sample stock solution: Nominally 1 mg/mL of nevirapine in Diluent prepared as follows. Transfer nevirapine, from finely powdered Tablets (NLT 20), to a suitable size volumetric flask, and add 75% of the final volume with Diluent. Sonicate the solution for 20 min, then shake for 20 min. Cool to room temperature, and dilute with Diluent to volume. Centrifuge a portion of the resulting solution at 1500 rpm for 5 min.

Sample solution: Nominally 0.025 mg/mL of nevirapine in Diluent from the Sample stock solution. Filter a portion of the resulting solution, and discard the first 2 mL of the filtrate.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 214 nm

Column: 3.9-mm x 15-cm; packing L1

Flow rate: 1 mL/min

Injection size: 20 µL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 3.0 between nevirapine and nevirapine related compound A, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of nevirapine (C₁₅H₁₄N₄O) in the portion of Tablets taken:

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

r_U = peak response of nevirapine from the Sample solution 

r_S = peak response of nevirapine from the Standard solution s

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

C_U = nominal concentration nevirapine in the Sample solution (mg/mL)

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

4.1 DISSOLUTION (711)

Medium: 0.1 M phosphate buffer, pH 2.0 (transferring 3.9 mL/L of concentrated phosphoric acid and 5.73 g/L of monobasic sodium phosphate monohydrate in water, adjust with phosphoric acid to a pH of 2.0 ± 0.02); 900 mL

Apparatus 2: 50 rpm. [NOTE-Use stainless steel paddles only. Do not use paddles coated with polytetrafluoroethylene.]

Time: 60 min

Mobile phase, Diluent, Chromatographic system, and System suitability: Proceed as directed in the Assay.

Standard stock solution A: 0.054 mg/mL of USP Nevirapine Anhydrous RS. Add 10% of the final volume with alcohol and 50% of the final volume of Medium. Sonicate for 20 min to dissolve, allow to cool to room temperature, and dilute with Medium to volume.

Standard stock solution B: 0.028 mg/mL of USP Nevirapine Related Compound A RS. Add 0.8% of the final volume of Diluent, sonicate until completely dissolved, and dilute with Medium to volume.

Standard solution: 0.014 mg/mL of USP Nevirapine Anhydrous RS from Standard stock solution A in Medium

System suitability solution: 0.014 mg/mL of USP Nevirapine Anhydrous RS from Standard stock solution A and 0.014 mg/mL of USP Nevirapine Related Compound A RS from Standard stock solution B in Medium

Sample solution: Pass 20 mL of the solution under test through a suitable nylon or glass fiber filter of 0.45-µm pore size, and dilute with Medium to obtain a solution having a final concentration of 0.014 mg/mL of nevirapine.

Analysis

Samples: Standard solution and Sample solution

Determine the percentage of the labeled amount of nevirapine (C₁₅H₁₄N₄O) dissolved:

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

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

D_U = dilution factor for the Sample solution 

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: NLT 75% (Q) of the labeled amount of nevirapine (CH, NO) is dissolved. 

4.2 UNIFORMITY OF DOSAGE UNITS (905)

Meet the requirements

5 IMPURITIES

ORGANIC IMPURITIES

Mobile phase, Diluent, System suitability solution, Sample stock solution, and Sample solution: Proceed as directed in the Assay.

Standard solution: 0.125 µg/mL of USP Nevirapine Anhydrous RS in Diluent

Chromatographic system: Proceed as directed in the Assay, except use a run time of at least 13 min.

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 3.0 between nevirapine and nevirapine related compound A, System suitability solution

Relative standard deviation: NMT 5.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each unknown impurity in the portion of Tablets taken:

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

r_U = peak response of each unknown impurity from the Sample solution

r_S = peak response of nevirapine from the Standard solution

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

C_U = nominal concentration nevirapine in the Sample solution (mg/mL)

[NOTE-Disregard all peaks due to the solvent or excipients and impurity peaks less than 0.1%.]

Acceptance criteria

Individual unknown impurity: NMT 0.1%

Total unknown impurities: NMT 0.2%

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed containers. Store at controlled room temperature.

USP REFERENCE STANDARDS (11)

USP Nevirapine Anhydrous RS

USP Nevirapine Related Compound A RS

5,11-Dihydro-6H-11-ethyl-4-methyl- dipyrido[3,2-b:2',3'-e] [1,4]diazepin-6-one

C₁₄H₁₄N₄O          254.29