STABILITY INDICATING METHOD DEVELOPMENT FOR THE ESTIMATION OF ABACAVIR AND LAMIVUDINE IN BULK AND FORMULATION
Rani Jatav, Dr L. K Omray
ABSTRACT
This research focuses on the development and validation of a stability-indicating method for the precise estimation of Lamivudine (LAMI) and Abacavir (ABCV) in both bulk and pharmaceutical formulations. The chromatographic method, utilizing high-performance liquid chromatography (HPLC), demonstrates robustness and reliability in assessing the quality and stability of these antiretroviral drugs. The system suitability parameters, linearity, recovery, precision, sensitivity, and forced degradation studies were comprehensively evaluated to validate the method's efficacy. The results reveal a strong linear relationship between concentration and response, with high correlation coefficients for both LAMI and ABCV. The method demonstrates accuracy through recovery studies, with values close to 100?ross different concentration levels. Precision studies confirm the consistency and reproducibility of the method. Additionally, low limits of detection and quantification highlight the method's sensitivity. Forced degradation studies indicate the susceptibility of LAMI and ABCV to specific stress conditions, providing crucial insights into potential degradation pathways. Overall, the developed method stands as a reliable tool for routine quality control analysis and stability assessment of LAMI and ABCV in pharmaceutical formulations.
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