Abstract

GREEN STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR PIMAVANSERIN HEMITARTRATE

Santosh Vilaschand Gandhi* and Vipul Vasant Bhamare

ABSTRACT

A straightforward, accurate, and stability-indicating High-Performance Thin Layer Chromatographic technique was developed and validated for the quantitative analysis of Pimavanserin Hemitartrate in pharmaceutical formulations. This method utilized pre-coated silica gel 60 F254 TLC plates as the stationary phase, with a mobile phase composed of Acetone: Methanol: Triethylamine (5:4.5:0.5 v/v/v). Detection occurred at 225 nm, where the drug displayed a distinct band with an Rf value of 0.79. Forced degradation studies were conducted under acidic, basic, oxidative, thermal, and photolytic conditions, adhering to ICH Q1A(R2) and Q1B guidelines to confirm the stability-indicating properties of the method. The method was validated according to ICH Q2(R1) guidelines, demonstrating excellent linearity within the range of 2000–12000 ng/band (R² = 0.9986). The percentage recovery in accuracy assessments varied from 100.332 % to 101.718 %, while the assay of the marketed formulation indicated a recovery of 100.813 %. Precision studies, both intra- and inter-day, resulted in %RSD values of less than 2%. The method proved to be robust, with %RSD remaining below 2% despite intentional alterations in analytical conditions. The limits of detection (LOD) and quantification (LOQ) were determined to be 358.896 ng/band and 1087.564 ng/band, respectively. The proposed HPTLC method is specific, robust, and appropriate for routine analysis and stability evaluation of Pimavanserin Hemitartrate in both bulk and marketed formulations.

Keywords: Pimavanserin Hemitartrate, HPTLC, Stability Indicating method, method validation, forced degradation, Green analysis.