A VALIDATED RPHPLC METHOD FOR THE DETERMINATION OF IMPURITIES IN TAMSULOSIN HCL
Keywords:
RP‐HPLC, Tamsulosin HCl, Impurities, Degradation products, Validation.Abstract
A simple and rapid reversed phase high performance liquid chromatographic method for the separation and determination of process related
impurities of Tamsulosin HCL (TAM) was developed. The separation was achieved on a reverse phase C18 column using the gradient LC method,
solution A and solution B as mobile phase. The solution A contains aqueous ortho phosphate buffer pH 6.5 and solution B contains a mixture of
water: acetronitrile (90:10%v/v). The method was linear over a range of 0.2 to 1.9µg/ml for process related impurities and 0.2 to 12.8µg/ml for
Tamsulosin HCL. The recoveries were found to be in the range of 92.14 to 104.44% for impurities as well as Tamsulosin HCL. The precision and
robustness of the method were evaluated. It was subjected to the stress condition of oxidative, acidic, basic, hydrolytic, thermal and photolytic
degradation. The degradation products were well resolved from the main peak and its impurities, proving the stability indicating power of the
method. It was used not only for quality assurance, but also for monitoring the synthetic reaction involved in the process development work in the
laboratory. The method was found to be specific, precise and reliable for the determination of un reacted levels of raw materials, intermediates in
the reaction mixtures and the finished products of Tamsulosin HCL.
