Analytical Method Development and Validation for the Simultaneous Estimation of Abacavir and Lamivudine by Reversed‑phase High‑performance Liquid Chromatography in Bulk and Tablet Dosage Forms

ABSTRACT

Objective:A simple rapid, accurate, precise, and reproducible validated reverse phase high performance liquid chromatography (HPLC) method was developed for the determination of Abacavir (ABAC) and Lamivudine (LAMI) in bulk and tablet dosage forms. Methods: The quantification was carried out using Symmetry Premsil C18 (250 mm × 4.6 mm, 5 μm) column run in isocratic way using mobile phase comprising methanol: water (0.05% orthophosphoric acid with pH 3) 83:17 v/v and a detection wavelength of 245 nm and injection volume of 20 μl, with a flow rate of 1 ml/min. Results: In the developed method, the retention times of ABAC and LAMI were found to be 3.5 min and 7.4 min, respectively. The method was validated in terms of linearity, precision, accuracy, limits of detection, limits of quantitation, and robustness in accordance with the International Conference on Harmonization guidelines. Conclusion:The assay of the proposed method was found to be 99% – 101%. The recovery studies were also carried out and mean % recovery was found to be 99% – 101%. The % relative standard deviation from reproducibility was found to be <2%. The proposed method was statistically evaluated and can be applied for routine quality control analysis of ABAC and LAMI in bulk and in tablet dosage form.

KEYWORDS

• Abacavir
• Dosage forms
• Lamivudine
• Method development
• Reverse phase high performance liquid chromatography
• Validation

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• DOI10.4103/pr.pr_96_17Copy

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