Development and validation of RP-HPLC method for quantification of sertraline in nanofiber formulation

Abstract

A selective serotonin reuptake inhibitor (SSRI) sertraline (SER) is one of the most often prescribed medications for the treatment of depression. The current study was aimed to develop a new, reliable, simple, and reproducible method for the estimation of SER in nanofiber formulation. The RP-HPLC method selected for estimation and validation was developed by choosing a mobile phase phosphoric acid (0.5%) and acetonitrile at the ratio 45: 55 %v/v, with a flow rate of 1 mL/min at a temperature of 30 ℃. The linearity of the solution was detected at 274 nm within the concentration range from 20 -120 µg/mL with a correlation value (R2) of 0.999 indicating a very strong relationship between dependent and independent variables suggesting the accuracy of the method selected. The concentration of SER in nanofibers was determined by the currently developed method. Validation parameters were used to evaluate, specificity, linearity, sensitivity, accuracy, precision, and ruggedness. About 98-102 (%v/v) of SER was found to be within standard limits and compliant with the standards set by the International Council of Harmonization (ICH) demonstrating the accuracy of the method used. An ICH Q2 (R1) guideline gives guidance on validation for analytical techniques. The RP-HPLC method developed can be used effectively for the analysis of various pharmaceutical dosage forms containing SER.