Paper Contents
Abstract
Objective: A rapid, sensitive, selective, and reproducible reversed-phase high-performance liquid chromatographic method has been developed and validated for the determination of Lamivudine in bulk and marketed pharmaceutical dosage forms.Methods: The chromatographic separation was carried out in an isocratic mode on a Symmetry C18 (250mm x 4.6mm, 5m particle size) column with a mobile phase consisting of Methanol and Phosphate Buffer (0.05M) pH-3.8 with Ortho Phosphoric Acid in the ratio of 55:45% vv at a flow rate of 1.0 mlmin. The run time was maintained for 7.0 min and detection was monitored at 232nm. Results: The retention time of Lamivudine was found to be 3.075 min. Calibration curve were linear over a concentration range of 616 gml with correlation coefficient 0.9998. The limit of detection and limit of quantification for Lamivudine was found to be 0.85gml and 2.55gml respectively. The intra- and inter-day precision was 9.0% and the accuracy ranged from 98% to 102% over the linear range. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, and ruggedness. Conclusion: This method was found to be simple, selective, precise, accurate, and cost-effective. Hence, the method can be successfully applied to analyze the Lamivudine concentration in bulk and marketed pharmaceutical dosage forms.
Copyright
Copyright © 2024 B. Vasanth Kumar, Rizwana Begum, Sowmya, A.Yasodha. This is an open access article distributed under the Creative Commons Attribution License.
