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Manipal Journal of Pharmaceutical Sciences

Abstract

India is today, one of the top emerging markets in the global pharmaceutical landscape. The sector is highly knowledge-based and its steady growth is positively affecting the Indian economy. The targets of the global pharmaceutical companies are always "First to File" with "Right time-first time" approach. A successful organization always differentiates itself for their process. It works with a vision, leveraging on new technologies and ideas. In order to have more confidence in data and to understand the analytical development process better, we need to introduce some orthogonality in our analytical development process like the mass detectors. In order to automate and fasten the process of method development and transfers, Pharmaceutical scientists uses UPLC’s. It is an LC system with inbuilt features to support faster method developments like automated solvent/pH/ salt blending and has softwares assisting in method transfers across LC platforms. The adoption of UPLC methods for various tests by different regulators like US-FDA, EMEA as release methods or alternative methods and adoption of UPLC by EP and USP in their monographs (NF and MC) clearly reflects the reason for the increase in trend with respect to its implementation. Hence, Pharmaceutical companies can leverage upon the new technologies to increase the throughput efficiency and differentiate oneself in this competitive world.

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