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STUDY OF QUANTIFICATION OF IMPURITIES AND RELATED SUBSTANCES IN A STATIN USING HPLC TECHNIQUE - METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYSIS

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Bulk drug during its production process, after its scale up, it is necessary to analyse for the presence of any impurities or related substances in it. This is to ensure the impurities and related substances are within their limits as per ICH Guidelines.

Required brief study 

      The primary objective of the study is to develop HPLC method and validate it for the detection and quantification of impurities and related substances in the manufacturing batch of statins and to ensure regulatory compliance as per ICH Guidelines.

 

 

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Drkrish...

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