METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF LAMIVUDINE AND DOLUTEGRAVIR IN BULK AND FORMULATION BY UV SPECTROSCOPY

Abstract

A simple, rapid, precise and accurate spectrophotometric method has been developed for quantitative analysis of Dolutegravir and Lamivudine in tablet formulations. Standard stock solutions were prepared by dissolving separately 100 mg of each drug in 80 mL methanol and the flask was sonicated for about 10 min to solubilize the drug. The maximum absorbance of LAM and DLT was observed at 244.0 nm and 262.0 nm, respectively. LAM and DLT showed linearity in the concentration range of 10-50 μg/ml and 5-25 μg/ml at their respective maxima. The recovery of added standards (80 %, 100 % and 120 %) was found at three replicates and three concentrations level. The value of % means just close to 100, SD and % RSD are less then 2 indicate the accuracy of method. Parameters like linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported within the ICH guidelines. The assay value in tablet formulation was close to 100, SD and % RSD are less than 2 indicates no interference of excipients in the estimation of drugs. Correlation coefficient of Dolutegravir and Lamivudine was found to be 0.999 and 0.998 respectively. Developed method was found to be novel, accurate, precise, selective and rapid for simultaneous estimation of DLT and LAM. The method was validated as per the ICH guidelines. The developed method can be adopted in routine analysis of Dolutegravir in bulk or tablet dosage form and it involves relatively low cost solvents and no complex extraction techniques.