Derivative UV Spectroscopic Cleaning Method Development and Validation of Darunavir API incorporated into Dissolving Oral Film

Abstract

A new UV spectrophotometric technique was developed and validated for Darunavir API by using oral film. The drug was analyzed using a UV spectrophotometric technique, and its linearity, accuracy, precision, and robustness were determined by ICH guidelines. Acetonitrile was the solvent used, and 263nm was shown to be the wavelength. R2=0.9989 shows that the method was linear in the range of 2 to 16µg/ml. Method precision was carried out and RSD was found to be 0.933. The accuracy values obtained from testing at three levels were 99.8, 100.7, and 99.4 in (50,100,150%). The residues are collected using the swab sample technique on a 10cm2 stainless steel plate. To collect the residue, swab sticks are used to stripe the SS plate in three directions: horizontally, vertically, and diagonally. Forced Degradation studies were conducted for API and Synthetic mixture at various conditions and the % degradation was recorded. The proposed method was used for the synthetic mixture of Darunavir API which has its application in formulating OSD. An assay of oral films was done which obeys the beers lambert law in the concentration of 3.27µg/ml. Recovery studies gave statistical confirmation and support for the analysis's conclusions