Development and validation of a stability indicating liquid chromatographic method for simultaneous estimation of Dutasteride and Tamsulosin in combined dosage form

Abstract

A novel stability indicating isocratic, reversed phase-liquid chromatographic method has been developed and validated for simultaneous quantitative determination of Dutasteride (DTS) and Tamsulosin (TAM) in combined pharmaceutical dosage form. An ACE C18 (250*4.6*5μ) column with mobile phase containing pH 5.2 (Potassiumdihydrogenphosphate) Buffer: Methanol in the ratio of 600:400 (v/v) was used. The flow rate was 1.0 mL/min, column temperature was 30°C and effluents were monitored by using a photodiode array detector at 247 nm. The retention times of Dutasteride and Tamsulosin were found to be 2.419 min and 5.119 min, respectively. Correlation co-efficient for Dutasteride and Tamsulosin were found to be 0.99 and 0.99, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. Recovery of Dutasteride and Tamsulosin in formulations was found to be in a range of 97-103% and 97-103% respectively and this confirms the non-interferences of the excipients in the formulation. Dutasteride and Tamsulosin were exposed to stress conditions like acidic hydrolysis, basic hydrolysis, oxidative, photolytic, humidity and thermal conditions. Due to its simplicity, rapidness and high precision, this method was successfully applied to the estimation of Dutasteride and Tamsulosin in combined dosage form.