Abstract

STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CLOZAPINE IN PHARMACEUTICAL DOSAGE FORM

Talreja Vinita*, Priyanka Yadav and Dr. Hiral Panchal

ABSTRACT

A specific, sensitive, accurate, precise and robust Gradient Reversed phase High Performance Liquid Chromatography method was Developed and Validated for Clozapine, using Cosmosil C18 (250mm x 4.6 mm x 5 μm) column with a flow rate 1.0 ml/min and Detection Wavelength of 238 nm. The Mobile Phase A is Buffer (Phosphate Buffer, pH 4.4): Acetonitrile (40:60) with retention time (RT) 8.017 min. The Samples were analyzed using 20 μL injection volume. The stability-indicating capability of method was established by forced degradation studies of bulk and pharmaceutical dosage form. The developed method was validated as per International Conference on Harmonization (ICH) for specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. Stability Indicating Study suggested that Major degradation of bulk was observed in Thermal condition and of dosage form was observed in Oxidative condition. Correlation co-efficient for calibration curve Clozapine was found to be 0.9912. The RSD for precision and robustness was found less than 2.

Keywords: Clozapine, Stability Indicating Method, HPLC, Validation.