Novel RP-HPLC Method for Simultaneous Estimation of Doxofylline and Sertraline in Bulk and Tablet Dosage Form

Abstract

The objective of this study was to de evelop a simple, rapid, accurate and precise isocratic sta tability indicating reversed-phase high-performance liquidid chromatographic method for simultaneous estimation n of Doxofylline and Sertraline in tablet dosage form. Thhe separation method was carried out using Std XDB C1 18 column (150 x 4.6 mm; 5μ).The mobile phase used wa as a mixture of Acetonitrile and Potassium Di Hydrogen PPhosphate buffer in the ratio of 45: 55(v/v) delivered at an isocratic flow rate of 0.8mL/min. Column temperatu ture was 30°c and eluents were monitored at 231nm usin ng Waters 2695 HPLC instrument equipped with the w waters 2998 PDA detector and Empower-2 software for ddata collecting and processing. With the optimized meth thod, the retention times of Doxofylline and Sertraline we ere found to be 2.06 min and 4.14 min respectively, with h theoretical plate count and asymmetry as per the ICH lim mits. The method has shown a good linearity in the conce entration range of 100–600 μg/ml for Doxofylline and 122.5–75μg/ml for Sertraline with regression coefficient (R2) of 0.999 and 0.997.The percentage assays were foun nd to be 99.11 and 96.44 for Doxofylline and Sertraline. The method was found to be accurate (with percentage m mean recoveries 99.71 for Doxofylline, and 99.10 for Serrtraline), precise, robust, reliable, specific and stable. Th he proposed method was validated in accordance with ICHH guidelines and hence this method can be successfullyy used for quantitative analysis of Doxofylline and Se Sertraline in tablet formulations.