A sensitive HPLC method for simultaneous estimation of tamsulosin hydrochloride and its impurity.

Tamsulosin hydrochloride is used to treat the symptoms of an enlarged prostate, a condition technically known as benign prostatic hyperplasia or BPH. The analyte was resolved by using mobile phase (potassium dihydrogen orthophosphate and acetonitrile) at the flow rate of 1.2 Ml/Min. on isocratic HPLC system consisting of Jasco Make UV visible detector of model UV 1575 and Jasco make HPLC pump of model PU 1580. An ODS C-8 RP column (4.6 mm ID, 250 mm L, particle size 5 micron, at wavelength of 280 Nm. The linearity range was found to be 0.4 Ml/Ml for tamsulosin and 0.12 mg/ml to 2.0 mg/ml for its impurity. The proposed method is simple, accurate, rapid and selective. Percent relative standard deviation was found to be very low, below 2.0%, which indicates that method is highly precise and specific. Short analysis time (<10 min.) coupled with simplicity and ease of operation warrants use of the given method for analysis of tamsulosin hydrochloride along with its impurity as stated above in bulk. Therefore, method can be useful in routine quality control analysis in bulk drugs.