DEVELOPMENT AND VALIDATION OF GREEN RP-HPLC AND SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF ALPELISIB IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Objective: This study aims to develop and validate green analytical methods, specifically UV spectrophotometry, first-order derivative spectrophotometry, and reverse-phase HPLC (RP-HPLC), for determining Alpelisib (ALP) in bulk and pharmaceutical formulations. By comparing the methods using GAPI and AGREE metrics, the study evaluates their environmental friendliness, precision, and applicability. Material and Method: The UV spectrophotometric and RP-HPLC analyses were conducted using Shimadzu UV 1800 and Agilent 1100 HPLC systems, respectively. The mobile phase for HPLC comprised 0.1% trifluoroacetic acid in water, acetonitrile, and methanol (50:25:25 v/v/v). ALP tablets were prepared and analyzed after dissolution in methanol/water (50:50 v/v) and filtration. Validation was conducted according to ICH guidelines. Result and Discussion: The developed methods showed high precision, robustness, and sensitivity. UV and HPLC methods were effective in determining ALP in both bulk drug and tablet formulations, with detection limits of 0.078 μg/ml for direct UV spectrophotometry and 14 μg/ml for RP-HPLC. Greenness evaluation highlighted the methods' environmental compatibility, making them suitable for sustainable pharmaceutical analysis.