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International Journal of Pharmacy and Pharmaceutical Science

Vol. 6, Issue 1, Part A (2024)

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

Author(s):

Sonali Kantale, Dr. AV Chandewar, Dr. AP Dewani, CK Gadewar and GO Karwa

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 (ABV) and Lamivudine (LAM) in bulk and tablet dosage forms.
Methods: The quantification was carried out using C18 (Hypersil gold) /4.6 x 250 mm column run in isocratic way using mobile phase comprising Acetonitrile: 0.1% orthophosphoric acid 45:55 v/v and a detection wavelength of 290 nm and injection volume of 20 μl, with a flow rate of 1 ml/min. 
Results: In the developed method, the retention times of ABV and LAM were found to be 4.739 min and 3.834 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 ABV and LAM in bulk and in tablet dosage form.

Pages: 57-64  |  60 Views  23 Downloads


International Journal of Pharmacy and Pharmaceutical Science
How to cite this article:
Sonali Kantale, Dr. AV Chandewar, Dr. AP Dewani, CK Gadewar and GO Karwa. 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. Int. J. Pharm. Pharm. Sci. 2024;6(1):57-64. DOI: 10.33545/26647222.2024.v6.i1a.114