Development And Validation of Stability Indic...

Development And Validation of Stability Indicating RP-HPLC Method For the Simlutanous Estimation of Deflazacort and Tamsulosin in API and Tablet Formulation

Author Name : Kanna Laxmi Sidram, Tamboli A. M

ABSTRACT A stability indicating Reverse Phase High Performance Liquid Chromatographic method has been developed and validated for the simultaneous estimation of Deflazacort and Tamsulosin in bulk and formulation. The chromatographic separation was achieved by using Agilent Zorbax Bonus-RP (250 mm x 4.6 mm, 5 μ) with the mobile phase comprising of Methanol: 0.1% Formic acid in Water in the ratio 78: 22 v/v. The flow rate was 1ml/min and the separated Deflazacort and Tamsulosin was detected by Diode array detector (DAD) at 282.0 nm. The retention time of Deflazacort and Tamsulosin was found to be 3.71 minutes and 1.75 minutes respectively. The column temperature was 30ºC with injection volume of 10μl. The linearity data showed good linear relationship within concentration range of 2.4-5.6 μg/ml for Tamsulosin and 180-420 μg/ml for Deflazacort with linear regression coefficient to be r2= 1 for both Tamsulosin and Deflazacort. The method obeyed the ICH guidelines. The method was successfully validated in accordance to the ICH guidelines for accuracy, precision, specificity, linearity, ruggedness and robustness.Force degradation study was also performed. The proposed method was found to be sensitive, accurate, precise, economic, reproducible and consistent.