Development and Validation of a Rapid - Chemo Metrics Assisted RPHPLC with Photodiode Array Detection method for the Simultaneous estimation of Dutasteride and Tamsulosin Hydrochloride in Pure and Pharmaceutical Formulation

The objective of the present study is to develop and validate a simple, precise, accurate and rapid chemo metrics assisted RP-HPLC method for the simultaneous estimation of the dutasteride and tamsulosin Hcl in pure and pharmaceutical formulation. During optimization, Central composite design (CCD) in resoponse surface methodology (RSM) was used. Percentage of organic segment (methanol) in mobile phase and the flow rate were selected based on the trial and error. Resolution (Rs2) and retention time (tR2) were used for the estimation of system response during the optimization procedure. Derringer’s desirability function was used to concurrently optimize the selected two responses. Resolution (Rs2) was achieved on a phenomenex C18 Column (150 X 4.6 mm i.d, 5μ particle size) with a mobile phase consisting of methanol and water (80:20 % v/v).The flow rate was 1.2ml/min and photodiode array detection at 235nm. The calibration curves were found to be linear from 15-45 μg/ml and 12-36μg/ml for dutasteride and tamsulosin Hcl with their correlation coefficients values (R2) 0.9999 and 0.9998. LOD and LOQ were found to be 0.0105μg/ml and 0.0318μg/ml for dutasteride and 0.0021μg/ml and 0.0063μg/ml for tamsulosin HCl. Accuracy reported as % recovery were found to be close to 100 % at all the levels. The method is simple and rapid and does not require any prior sample treatment. The method was fully validated. The validated method was successfully employed for the simultaneous estimation of dutasteride and tamsulosin HCl in pure and pharmaceutical formulation.

Author(s): P. Giriraj, T. Siva k kumar

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