RP-HPLC method development and validation for simultaneous estimation of sertraline HCL and alprazolam in tablet dosage form

Abstract

To develop a simple and selective method for the simultaneous determination of sertraline and Alprazolam in tablet dosage forms. A simple, rapid, accurate, specific and sensitive reverse phase-HPLC method has been developed and validated for the simultaneous estimation of Sertraline HCl and alprazolam in pharmaceutical dosage form. The chromatographic separation was performed on Symmetry C18 (4.6 x 250mm, 5µm, Make: Waters) using a mobile phase of phosphate buffer: acetonitrile (40:60v/v), at a flow rate of 1.ml/min at ambient temperature with the detection wave length at 225nm. The retention times of Alprazolam and Sertraline HCl were 2.342 min and 3.282 min respectively. The linearity was performed in the concentration range of 5 -25 µ g/ml  and 100-500 µg/ml  with a correlation coefficient of 0.999 respectively. The percentage purity of Sertraline HCl and Alprazolam was found to be 99.8 and 100.4% w/v respectively. The proposed method has been validated for linearity, precision, accuracy and robustness were within the acceptance limit according to ICH guidelines and the developed method was successfully employed for routine quality control analysis in the combined pharmaceutical dosage forms.