Anti Retro Virals

Test

Limits as per BP

Description

White coloured round shaped biconvex film coated tablet.

Identification

Should comply as per BP

Average weight of 20 Tablet

195.70 mg ± 7.5 %

Uniformity of Weight

± 7.5% of average weight

Thickness

3.40 ± 0.20 mm

Diameter

8.00 mm ± 0.10 mm

Disintegration Time

NMT 30 min

Dissolution

NLT 75% (Q)

Assay:

Each film-coated tablet contains

Zidovudine BP 100 mg

95.0% to 105.0% of L A

Related Substances

Should comply as per BP

Test

Limits as per BP

Description

White coloured round shaped biconvex film coated tablet.

Identification:

IR Absorption:

Should comply as per BP

The chromatogram obtained with solution 1 should show two principal spots corresponding in position, colour and size to the principal spots in the chromatograms obtained with solutions 2 and 3.

In the assay, chromatogram obtained with solution 1 should show principal peaks with same retention time as the principal peaks due to Zidovudine and Lamivudine in the chromatograms obtained with solutions 2 and 3.

Average weight of 20 Tablet

565.50 mg ± 3%

Uniformity of Weight

± 7.5% of average weight

Thickness

4.20 ± 0.20 mm

Diameter

12.60 mm ± 0.10 mm

Disintegration Time

NMT 30 min

Dissolution

Zidovudine BP NLT 75% (Q)

Lamivudine BP NLT 75% (Q)

Assay by HPLC: Each film-coated tablet contains Zidovudine BP 300 mg

Lamivudine BP 150 mg

95.0% to 105.0% of L A

285.00 mg to 315.0 mg

142.50 mg to 157.50 mg

Related Substances

Should comply as per BP