Nateglinide Tablets

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

Nateglinide Tablets contain NLT 95.0% and NMT 105.0% of the labeled amount of nateglinide (C₁₉H₂₇NO₃).

2 IDENTIFICATION

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

Diluent: Acetonitrile and water (11:9)

Mobile phase: Acetonitrile and 0.05% solution of trifluoroacetic acid (23:27)

Standard solution: 0.72 mg/mL of USP Nateglinide RS prepared as follows. Transfer USP Nateglinide RS to a suitable volumetric flask, and add acetonitrile to 40% of the volume of the flask. [NOTE-Sonicate to dissolve.] Add water equivalent to 30% of the final volume, mix, cool the solution to room temperature, and dilute with Diluent to volume.

Sample solution: Place 20 Tablets into a 500-mL volumetric flask, and add 60 ml of water to disintegrate the Tablets. [NOTE-Sonicate with cooling, if necessary.] Add 280 mL of acetonitrile, and shake by mechanical means for at least 30 min. Dilute with Diluent to volume. Pass a portion through a 0.45-µm glass microfiber filter, discarding the first 10 mL of the filtrate, or use centrifugation to obtain a clear solution. Dilute an aliquot of this solution with Diluent to obtain a solution having a concentration of 0.72 mg/mL based on the label claim.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.6-mm x 15-cm; 5-µm packing L1

Flow rate: 1.5 mL/min

Injection size: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 1.8

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled quantity of C₁₉H₂₇NO₃ in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of the Standard solution (mg/mL)

C_u = nominal concentration of the Sample solution (mg/mL)

Acceptance criteria: 95.0%–105.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: 0.01 N hydrochloric acid containing 0.5% (w/v) of sodium lauryl sulfate; 1000 mL

Apparatus 2: 50 rpm

Time: 30 min

Determine the quantity of C₁₉H₂₇NO₃ dissolved by employing the following method.

Solution A: 6.9 mg/mL of monobasic sodium phosphate. Adjust with phosphoric acid to a pH of 2.5.

Mobile phase: Acetonitrile and Solution A (45:55)

Standard stock solution: 0.3 mg/mL of USP Nateglinide RS prepared as follows. Transfer USP Nateglinide RS to a suitable volumetric flask, dissolve in a small volume of acetonitrile not exceeding 5% of the final volume, and dilute with Medium to volume.

Standard solution: 0.12 mg/mL of USP Nateglinide RS in Medium, from the Standard stock solution

Sample solution: Pass through a suitable filter with pore size of 0.7 µm.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.6-mm x 5-cm; 5-µm packing L1

Flow rate: 1.5 mL/min

Injection size: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Standard solution and Sample solution

Samples:

Calculate the percentage of C₁₉H₂₇NO₃ dissolved:

Result = (r_u /r_s ) × (C_s × V) × (100/L)

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of the Standard solution (mg/mL)

V = volume of Medium, 1000 mL

L = label claim (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of C₁₉H₂₇NO₃ is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, and store at controlled room temperature.

USP Reference Standards 〈11〉

USP Nateglinide RS