Abstract
A rapid and sensitive reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous determination of Risperidone and Trihexyphenidyl hydrochloride in pharmaceutical formulations. The chromatographic separation was achieved using a Thermosil C18 column (4.0×125mm, 5μm) with a mobile phase consisting of methanol and sodium acetate buffer (pH 3.0) in the ratio of 70:30 v/v. The flow rate was maintained at 1.0 mL/min with UV detection at 252 nm. The retention times for Risperidone and Trihexyphenidyl hydrochloride were 2.566 and 3.417 minutes, respectively. The method demonstrated excellent linearity in the concentration ranges of 5-25 μg/mL for Risperidone and 50-250 μg/mL for Trihexyphenidyl hydrochloride, with correlation coefficients of 0.999 for both compounds. The method validation parameters including accuracy, precision, specificity, and robustness met ICH guidelines. The mean recoveries were 99.56% and 99.48% for Risperidone and Trihexyphenidyl hydrochloride, respectively. The limits of detection were 3.17 μg/mL and 0.0172 μg/mL, while the limits of quantification were 5.80 μg/mL and 0.212 μg/mL for Risperidone and Trihexyphenidyl hydrochloride, respectively. The validated method proved suitable for routine quality control analysis of both drugs in pharmaceutical formulations.
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