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e-ISSN: 2320-0812 p-ISSN: 2347-2340

Research & Reviews: Journal of Pharmaceutical Analysis
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Research Article

Isolation, Identification and Characterization of Unknown Impurity in Fermentation Based Active Pharmaceutical Ingredient Lovastatin.

Chandrakant Belwal*, Divyesh Patel, Kamlesh Chauhan, Yogendrasinh Parmar, Ajay Singh Rawat, and Anand Vardhan

Sterling Biotech Research Centre, A Corporate Research Centre Of Sterling Biotech Limited, Jambusar State Highway, Masar-391421, Vadodara, Gujarat, India.

*Corresponding Author:
Chandrakant Belwal
Sterling Biotech Research Centre,
A Corporate Research Centre Of Sterling Biotech Limited,
Jambusar State Highway, Masar-391421,
Vadodara, Gujarat, India.
Mobile: +91 9328979762

Received date: 22/09/2014 Revised date: 28/09/2014 Accepted date: 30/09/2014

 

Abstract

An unknown impurity in fermentation based drug substance lovastatin at 1.06 RRT was observed invariably in all batches when analyzed by HPLC as per Ph Eur. monograph. This impurity was isolated from the impurity enriched sample using reversed phase preparative HPLC and characterized by using spectroscopic (PMR, CMR, MASS and UV) and thermal analysis (DSC) techniques.

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