Zidovudine 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

Zidovudine Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of zidovudine (C₁₀H₁₃N₅O₄).

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

Sample: Grind 1 Tablet in a mortar so that no large pieces remain, and remove the coating lm so that about 5 mg of ground Tablet remain. 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: Dissolve 3.0 g of sodium acetate and 1.3 g of sodium 1-octane sulfonate in 900 mL of water. Add 90 mL of methanol and 40 mL of acetonitrile. Adjust with glacial acetic acid to a pH of 5.3.

Zidovudine related compound B standard stock solution: 0.1 mg/mL of USP Zidovudine Related Compound B RS in methanol Zidovudine related compound C standard stock solution: 0.2 mg/mL of USP Zidovudine Related Compound C RS in methanol prepared as follows. Dissolve by sonicating for 15 min before bringing the solution to volume.

Standard solution: 0.12 mg/mL of USP Zidovudine RS, 1 µg/mL of USP Zidovudine Related Compound B RS, and 4 µg/mL of USP Zidovudine Related Compound C RS prepared as follows. Transfer 30 mg of USP Zidovudine RS to a 250-mL volumetric flask, and dissolve in 3.0 mL of methanol. Add 2.5 mL of Zidovudine related compound B standard stock solution and 5.0 mL of Zidovudine related compound C standard stock solution, and dilute with water to volume.

Sample stock solution: Nominally 3 mg/mL of zidovudine prepared as follows. Transfer a number of Tablets, equivalent to 1500 mg of zidovudine, to a 500-mL volumetric flask. Add 50 mL of water, and shake by mechanical means for 30 min to disperse the Tablets. Add 150 mL of methanol, and sonicate for 10 min. Dilute with water to volume.

Sample solution: Nominally 0.12 mg/mL of zidovudine in water from Sample stock solution. Pass the solution through a nylon filter, discarding the first 2 mL of the filtrate.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 265 nm

Column: 4.6-mm × 15-cm; packing L1

Flow rate: 1.3 mL/min

Injection volume: 20 µL

3.2 System suitability

Sample: Standard solution

[Note—The relative retention times for zidovudine related compound C, zidovudine, and zidovudine related compound B are about 0.17, 1.0, and 1.2, respectively.]

Suitability requirements

Resolution: NLT 2.5 between the zidovudine and zidovudine related compound B peaks

Tailing factor: NMT 2.0 for the zidovudine peak

Relative standard deviation: NMT 2.0% for the zidovudine peak

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of zidovudine (C₁₀H₁₃N₅O₄) 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 USP Zidovudine RS in the Standard solution (mg/mL) 

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

Acceptance criteria: 90.0%–110.0% 

4 PERFORMANCE TESTS 

Dissolution 〈711〉 

Medium: Water; 900 mL 

Apparatus 2: 50 rpm 

Time: 30 min 

Standard solution: Prepare a solution having a known concentration of USP Zidovudine RS in Medium 

Sample solution: A filtered portion of the solution under test suitably diluted with Medium 

Analysis: 

Samples: Standard solution and Sample solution 

Determine the percentage of zidovudine (CC₁₀H₁₃N₅O₄) dissolved by using the procedure set forth in the Assay. 

Tolerances: NLT 80% (Q) of the labeled amount of C₁₀H₁₃N₅O₄ is dissolved. 

Change to read: 

Uniformity of Dosage Units 〈905〉: Meet the requirements (CN 1-Aug-2023)

Procedure for content uniformity

Mobile phase: Methanol and water (1:4)

Standard solution: Proceed as directed in the Assay.

Sample solution: Transfer 1 Tablet to a 100-mL volumetric flask, add 20 mL of water, and shake by mechanical means to disperse the Tablet. Add 30 mL of methanol, and sonicate for 10 min. Dilute with water to volume. Pipet 4.0 mL of the resulting solution into a 100-mL volumetric flask, and dilute with water to volume. Pass a portion of the solution through a suitable nylon filter, discarding the first 2 mL of the filtrate.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 265 nm

Column: 4.6-mm × 15-cm; base-deactivated packing L1

Flow rate: 2 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0 for the zidovudine peak

Relative standard deviation: NMT 2.0% for the zidovudine peak

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of zidovudine (C₁₀H₁₃N₅O₄), based on the label claim, in the portion of Tablet taken:

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

r_U = peak response of zidovudine from the Sample solution

r_S = peak response of zidovudine from the Standard solution

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

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

(CN 1-Aug-2023)

5 IMPURITIES

Organic Impurities

Mobile phase, Standard solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay. Analysis

Samples: Standard solution and Sample solution

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

Result = (r_U /r_S ) × (C_S /C_U) × (1/F) × 100

r_U = peak response of each impurity from the Sample solution

r_S = peak response of zidovudine from the Standard solution

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

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

F = relative response factor (see Table 1)

Acceptance criteria: See Table 1.

Table 1

a Process impurity. Included for identification purpose only. Not to be included in the Total impurities.

6 ADDITIONAL REQUIREMENTS

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

USP Reference Standards 〈11〉

USP Zidovudine RS

USP Zidovudine Related Compound B RS

3′-Chloro-3′-deoxythymidine.

C₁₀H₁₃ClN₂O₄   260.68

USP Zidovudine Related Compound C RS

Thymine.

C₅H₆N₂O₂   126.12