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Development and Validation of RP - HPLC Method for the Determination of Tamsulosin Hydrochloride

Mandava V. Basaveswara Rao, B. C. K. Reddy, M. Subba Rao and B. Sreedhar

A simple and precise isocratic reverse phase high performance liquid chromatographic method has been developed for the determination of tamsulosin hydrochloride pellets 0.2%. Good resolution was achieved with inertsil ODS 3V (5 microns, 15 x 4.6 mm) column, in an isocratic mode, using acetonitrile:buffer (30 : 70) as mobile phase. The flow rate is 2 mL/minute and elution was monitored at 220 nm. The factors involved in the method development are discussed. This method was validated as per International Conference on Harmonization (ICH) guidelines. The method is linear in the range 75 to 150 ppm. pH was adjusted to 3.0 with perchloric acid.