Validated Stability Indicating Method For The Determination Of Tamsulosin In Pharmaceutical Dosage Form By Rp-Hplc.

Abstract

Tamsulosin in its pharmaceutical dosage has determined by a new validated stability- indicating method using RP-HPLC. Kromasil (250 x 4.6 mm, 5µm) column and mobile phase comprising of Buffer (0.1% Ortho-phosphoric acid)-Acetonitrile (50:50, v/v) were used to achieve the chromatographic separation at a wavelength of 270 nm with 1.0 ml/minute flow rate. The suggested method was linear with correlation coefficient (R²= 0.9997) and regression equation y = 45801x + 2700.8. The limit of detection and limit of quantification were 0.010 and 0.031 respectively. The %RSD of precision, accuracy was < 2. Tamsulosin was subjected to stress conditions including acid, alkali, thermal, photolysis and oxidation degradation. Degradation of Tamsulosin was observed more in acidic medium. The proposed method was accurate, linear, precise, robust as per ICH guidelines.