ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF ALPRAZOLAM AND SERTRALINE HYDROCHLORIDE BY HPLC AND UV

The present study involves the development and validation of simple, accurate, and precise analytical methods for the simultaneous estimation of Alprazolam and Sertraline Hydrochloride in combined pharmaceutical dosage forms. Two methods were developed: UV spectrophotometry and reverse-phase high-performance liquid chromatography (RP-HPLC). The UV spectrophotometric method utilized the simultaneous equation method based on absorbance measurements at 260 nm and 273 nm, the respective λmax values of Alprazolam and Sertraline HCl. Both drugs obeyed Beer’s Law in the concentration range of 5–50 μg/mL, with high correlation coefficients, indicating good linearity. The method showed satisfactory precision and accuracy, making it suitable for routine analysis. The RP-HPLC method was performed using a C18 column and a mobile phase composed of methanol, acetonitrile, and phosphate buffer (pH 4.5) in the ratio 50:15:35 v/v, at a flow rate of 1 mL/min. Detection was carried out at 239 nm, and the retention times were found to be approximately 3.0 minutes for Alprazolam and 6.4 minutes for Sertraline HCl. The method was validated according to ICH guidelines, and parameters such as specificity, linearity, accuracy, precision, robustness, and sensitivity were within acceptable limits. Both methods were successfully applied to the estimation of the drugs in commercial tablet formulations. The developed methods are reliable and can be effectively employed in routine quality control and pharmaceutical analysis.