A Novel Stability Indicating RP-HPLC Assay Method Development and Validation for the Quantification of Cyamemazine Tartrate in bulk and its Pharmaceutical Dosage Form

A simple and rapid stability-indicating reverse phase HPLC assay procedure has been developed and validated for Cyamemazine tartrate in bulk and its Pharmaceutical dosage form. Chromatographic separation was achieved on Phenomenex Luna C18 (250 mm x 4.6, 5μ particle size) column using isocratic elution with mobile phase consisting of water, Acetonitrile and Methanol (60: 30: 10 v/v/v) under ambient temperature at 1.0 mL min−1. The procedure showed a dynamic linear response over 10–60 μg mL-1 demonstrating correlation coefficient (r²) above 0.999, with the limits of detection and quantitation of 1.72 and 5.23 μg mL-1 respectively. The batch injection repeatability for intra and inter assay precision and accuracy studies were within the acceptance. The analyte was subjected for various stress conditions. The procedure well separated Cyamemazine tartrate and its potential degradation products which prove the stability indicating nature of the method.