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Analytical Method Development and Validation for the Estimation of Silodosin and Dutasteride in Capsule Dosage Form by RP-HPLC Method

Nataraj KS*, Srinivasa Rao A, Harshitha S, Pravallika K

A simple, rapid, accurate, efficient and reproducible reverse phase high performance liquid chromatography (RPHPLC) method was developed and subsequently validated for simultaneous estimation of silodosin and dutasteride capsules. The analysis was carried out using Unison C8 column (250 mm x 4.6, 5 μm particle size) at 40°C temperature using mobile phase buffer:Methanol:Acetonitrile (20%:40%:40% v/v/v) at flow rate 1.0 ml/min. Quantification was achieved with PDA detector at a wavelength of 275nm. The silodosin peak retention time was 2.4 mins and the dutasteride retention was 10.9 mins, so the total run time was set to 14mins. The linearity range of Silodosin and Dutasteride is 20-120 μg/ml and 1.25-7.5 μg/ml respectively. Linear regression found to be 0.999. The proposed method was validated according to International Conference on Harmonisation (ICH) guidelines. The results shown in the method was accurate, precise, sensitive and economical. Thus, the current study showed that the developed reverse-phase liquid chromatography method is sensitive and selective for the estimation of Silodosin and Dutasteride in Capsule Dosage Form