Abstract
RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMINATION OF TAMSULOSIN HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

Md. Abdul Sattar* and Suneetha Achanta

ABSTRACT

A new method was established for estimation of Tamsulosin Hydrochloride by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tamsulosin Hydrochloride by using Intersil ODS C18 column (250×4.6mm) 5.0μm, flow rate was 1.0ml/min, mobile phase ratio was (60:40 v/v) Potassium dihydrogen o-phosphate Buffer: Acetonitrite pH 6.5 (pH was adjusted with Ortho-phosphoric acid), detectio wavelength was 220nm. The instrument used was Shimadzu HPLC, UV detector 2450, Empower-software version-2. The retention times of Tamsulosin Hydrochloride were found to be 5.4 mins. The % purity of Tamsulosin Hydrochloride was found to be 99.66%. The system suitability parameters for Tamsulosin Hydrochloride such as theoretical plates and tailing factor were found to be 4381 and 1.4, and the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Tamsulosin Hydrochloride was found in concentration range of 80μg-120μg and correlation coefficient (r2) was found to be 0.999 and % recovery was found to be with in limits 98.0% to 102.0%, %RSD for repeatability was 0.35 and, % RSD for intermediate precision was 0.15 respectively. The precision study was precise, robust, and repeatable. LOD value was 0.522, and LOQ value was 1.581 respectively.

Keywords: Intersil ODS C18 column, Tamsulosin Hydrochloride and RP-HPLC.


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