DEVELOPMENT OF A NEW ANALYTICAL METHOD AND VALIDATION OF TRIHEXYPHENIDYL HCL AND CHLORPROMAZINE HCL IN PURE AND PHARMACEUTICAL FORMULATION BY RP-HPLC

*Arshiya Tabbasum, Dr. N. Ravindra and Maryam Fatima

ABSTRACT

A New Simple Precise, Rapid, Specific, Accurate, Robust And Rugged Reverse-Phase High-Performance Liquid Chromatographic Method For The Simultaneous Analysis of Trihexyphenidyl Hcl and Chlorpromazine HcL in pure and pharmaceutical dosage form has been developed and validated as per ICH Guidelines. Chromatography was performed on a Hypersil ODS C18 (4.6mm×250mm) 5μm Particle Size column with Acetonitrile: Phosphate Buffer (0.05M) (pH-3.6) (28:72% v/v) used as mobile phase at a flow rate of 1.0 ml/min. UV detection at 224nm; Trihexyphenidyl HCL and Chlorpromazine HCL were eluted with retention times of 2.133, 3.692min respectively. The method was validated in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable and reproducible. Calibration plots were linear over the concentration ranges 30–70μg/ml for Trihexyphenidyl HCL, 60–140μg/ml for Chlorpromazine HCL. Limits of detection were 1.3μg/ml and 3.9μg/ml and limits of quantification were 1.9μg/ml and 5.7μg/ml for Trihexyphenidyl HCL and Chlorpromazine HCL respectively. The high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of the two drugs in tablets. Statistical analysis proves that the method is suitable for the analysis of Trihexyphenidyl HCL and Chlorpromazine HCL as a pure drug and in pharmaceutical formulation without any interference from the excipients.

Keywords: Trihexyphenidyl HCL and Chlorpromazine HCL, RP-HPLC, Validation, ICH Guidelines, Accuracy.