Stability Indicating Hptlc Method Development And Validation For Simultaneous Estimation Of Alfuzosin Hydrochloride And Tadalafil In Combined Dosage Form
Abstract
A simple, rapid, accurate, precise, and stability-indicating HPTLC method was developed and validated for the simultaneous estimation of Alfuzosin hydrochloride and Tadalafil in combined pharmaceutical dosage forms. Chromatographic separation was achieved on silica gel 60F254 HPTLC plates using Dichloromethane: Methanol: Toluene (6:3:1 v/v/v) as the mobile phase. Densitometric scanning was performed at 212 nm and produced well-resolved peaks for both analytes. The method was validated as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Q2(R1) guidelines for linearity, accuracy, precision, specificity, robustness, LOD, and LOQ. The method showed satisfactory linearity, accuracy, and precision with low %RSD values. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed the stability-indicating nature of the method. The developed HPTLC method was found to be suitable for routine quality control and stability analysis of combined dosage forms containing Alfuzosin hydrochloride and Tadalafil
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