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

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