Volume 1, Issue 10
Development and Validation of HPTLC Method for Quantification of Silodosin in Bulk and Pharmaceutical Dosage Form
Author: Sayana P. S., R. Shankar Iyer*, Shibi A., Harischandran S.
Abstract: A simple, sensitive, precise and specific high-performance thin layer chromatographic method was developed and validated for the determination of silodosin in bulk and Pharmaceutical Dosage Forms. Validation was carried out in compliance with International Conference on Harmonization guidelines. The thin-layer chromatographic method employed aluminium plates precoated with silica gel 60 F254 as stationary phase. The solvent system consisted of toluene/methanol/diethylamine (8:1:1).This solvent system was found to give compact spot for silodosin with Rf value 0.37. Densitometric analysis of silodosin was carried in the fluorescence mode at 366 nm. Linear regression analysis showed good linearity with respect to peak area in the concentration range of 140-1400 ng per spot. The method was validated for precision, accuracy, specificity, and robustness.
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