STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS DETERMINATION OF DUTASTERIDE AND TAMSULOSIN IN BULK AS WELL AS IN PHARMACEUTICAL DOSAGE FORM BY USING PDA DETECTOR

Abstract

ABSTRACT

Objective: The present work was undertaken with the aim to develop and validate a rapid and consistent stability indicating RP-HPLC in which the peaks will be appear with short period of time as per ICH Guidelines. The proposed method was simple, fast, accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. Method: Reversed-phase high-performance liquid chromatography (RP-HPLC) methods was developed and validated for simultaneous estimation of Tamsulosin hydrochloride and Dutasteride in bulk drug and in combined dosage forms. RP-HPLC separation was achieved on a Symmetry C18 (4.6 x 150mm, 5mm, Make: XTerra) under an Isocratic Mode. The mobile phase was composed of Phosphate Buffer (20%) whose pH was adjusted to 2.5 by using Orthophosporic Acid & Acetonitrile (80%) [HPLC Grade]. The flow rate was monitored at 0.8 ml per min. The wavelength was selected for the detection was 274 nm. Result: The run time was 7min. The retention time found for the drugs Dutasteride & Tamsulosin were 2.003 min. & 5.067 min. respectively. The linearity was established in the range of 25 to 125µg/ml. The proposed method was adequate sensitive, reproducible, and specific for the determination of Dutasteride and Tamsulosin hydrochloride in bulk as well as in Pharmaceutical dosage form. The validation of method was carried out utilizing ICH-guidelines. Conclusion: The described RP-HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. The drug was exposed to Thermal, Hydrolytic and Oxidative stress conditions and the stressed samples were analyzed by the proposed method. The peak homogeneity data for the drugs Dutasteride and Tamsulosin hydrochloride were obtained by using Photodiode Array Detector in the stressed sample chromatograms which demonstrated the specificity of the method for the estimation in the presence of degradants. Overall the proposed method was found to be suitable and Accurate for the Quantitative determination and stability study of the drug in Pharmaceutical dosage form. . The method was effectively separated the drug from its degradation product and it was employed as a stability- indicating one. The method was simple, precise, accurate and sensitive and applicable for the simultaneous determination of Dutasteride and Tamsulosin hydrochloride in bulk drug and in combined dosage forms.

Keywords: Tamsulosin, Dutasteride, ICH Guideline, RP-HPLC, LOD, LOQ.