Paper Contents
Abstract
This study presents the development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous analysis of Risperidone and Trihexyphenidyl Hydrochloride (HCl) in both bulk and pharmaceutical dosage forms. The aim is to provide a reliable, accurate, and efficient analytical tool for quality control and therapeutic monitoring of these compounds.The RP-HPLC analysis was performed using a Waters HPLC system equipped with an auto-sampler and a PDA Detector 996 model. The method utilized an Altima C18 column (4.6 150 mm, 5 m particle size) with a column temperature set at 35C. The mobile phase consisted of a mixture of methanol and acetonitrile in a 60:30 vv ratio. The flow rate was maintained at 1 mlmin, and detection was carried out at 260 nm. An injection volume of 10 l was used, with a total run time of 14 minutes.The method was optimized to achieve efficient separation and accurate quantification of Risperidone and Trihexyphenidyl HCl. Validation of the method followed standard protocols, including assessments of specificity, accuracy, precision, linearity, and robustness. The method demonstrated high specificity with clear resolution of the analytes, and accuracy within 2% of nominal values. Precision was confirmed with relative standard deviations below 1.5% for both intra-day and inter-day analyses. Linearity was established over concentration ranges with correlation coefficients exceeding 0.999 for both drugs. Robustness testing indicated minimal impact from small variations in chromatographic conditions.
Copyright
Copyright © 2024 Y Laxmi Prasanna. This is an open access article distributed under the Creative Commons Attribution License.
