Development and validation of stability indicating UPLC method for determination of  related impurities in Artesunate and Amodiaquine fixed dose tablets

By M.U. Phadke, V. K. Jadhav , D. Patil , S. Narayankar,  R. K. Jadhav, Y. K. Bansal

ABSTRACT


The HPLC gradient method can be succefully transferred on UPLC. Transfer of the method was accomplished by geometrically scaling flow rate, injection volume, and gradient profile. Analysis time was reduced by four fold with an improvement of 64% in the resolution of critical pair of artesunate and artemisinin. Sensitivity of UPLC over HPLC was evaluated by comparison of LOQ values of dihydroartemisinin and glycan obtained in gradient HPLC for both systems. The almost ten times lower LOQ values with higher precision are attributed towards better sensitivity of UPLC method. The present work demonstrated the ease of HPLC to UPLC method transferability, and the benefits that can be obtained in any time and resource. It proved that UPLC can significantly increase throughput with quality results. With variety of column dimensions, scientists have the flexibility to tailor their UPLC separations to the goals at hand.

 

Key words- UPLC, gradient, sub-micron particles, resolution, LOQ, HPLC

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