ABSTRACT:
An easy to use, clear, and reliable robust reversed-phase high-pressure liquid chromatography method was established and verified for the combined analysis of Haloperidol & Trihexyphenidyl in active pharmaceutical ingredient and combination tablet formulation. The compound separation through chromatographic technique was attained using a suitable octadecylsilane column with a solvent consisting of an optimized ratio of organic and aqueous solvents, under elution using a constant solvent composition. The absorbance was monitored at a wavelength suitable for both drugs using a Ultra-violet detector. The method was validated following international conference and Harmonization guidelines, assessing parameters such as specificity, linearity, accuracy, precision, detection limit, quantification limit, robustness, and system suitability. The method demonstrated good linearity over the concentration ranges studied, with correlation coefficients close to 1. Recovery testing proved the method to be accurate, and the low %Relative standard deviation values confirmed its consistent precision. The developed approach can be reliably used for regular quality assessment of Haloperidol & Trihexyphenidyl in raw drug substance & tablet formulation.
Cite this article:
Prathyusha Barla, Mangamma Kuna, Abeda Begum Shaik, Nikhil Deep Gunnada. Design and Validation of a RPHPLC Method for Concurrent Determination of Haloperidol and Trihexyphenidyl in API and Combined Tablet Formulations. IJRPAS, June 2025; 4 (6): 1-5.DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2025.4601
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