Tuesday , 19 March 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Sertraline hydrochloride and Alprazolam by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Gobala Krishnan P*, Munisekhar V, Ranjit singh B Rathore
Department of Pharmaceutical Chemistry, Vagdevi college of Pharmacy and Research centre, Nellore, A. P, India.

A B S T R A C T
The chromatographic conditions were successfully developed for the separation of Sertraline hydrochloride and Alprazolam by using C18 Column (150mm x 4.6mm) 5 µm, flow rate was 1 ml/min, mobile phase ratio was Methanol: Phosphate buffer PH 2.8 (55:45 v/v), detection wavelength was 225 nm. The Spectroscopic method was done in solvent using methanol and the instrument lab India 3000+ with UV win software. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, UV detector, Empower-software version 2. The retention times for Sertraline hydrochloride and Alprazolam were found to be 2.344 min and 3.286 min. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Sertraline hydrochloride and Alprazolam was found in the concentration range of 100 ppm-500 ppm and 1ppm -5 ppm and correlation coefficient (r2) was found to be 0.999 and 0.999 respectively, % recovery was found to be 98% and 102% respectively. %RSD for repeatability and precision was found to be <2. LOD and LOQ values were found to be within the limits for Sertraline hydrochloride and Alprazolam.
Keywords: Sertraline hydrochloride, Alprazolam, HPLC.

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