DEVELOPMENT AND VALIDATION FOR DETERMINATION OF LENACAPAVIR BY UV-SPECTROPHOTOMETRIC METHOD

A simple, rapid, accurate, and economical UV-Spectrophotometric method has been developed for determination of Lenacapavir in bulk and pharmaceutical formulation. The λmax of Lenacapavir in water was found to be 281 nm. The drug follows linearity in the concentration range 25-125 ppm with a correlation coefficient value of 0.999. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated was 99.19% and was found to be in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 50%, 100% and 150%. The % recovery was found to be in the range of 98.54-99.98%. The low values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intraday; interday variations, and repeatability. The % RSD value < 2 indicates that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts. Keywords: Lenacapavir, UV-Spectrophotometry, Analytical Method Validation, ICH Guidelines.