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ISSN 2063-5346
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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY BY HPLC FOR ESTIMATION OF DELAMANID

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Ashwini Pritam Shewale, Dr. Mohit Chaturvedi
» doi: 10.31838/ecb/2023.12.s3.100

Abstract

Establishing quality and quantity is one of the prime concerns of any pharmaceutical industry for successful release of drug into the market. Not only for release of drug in to the market, had assurance on quality and quantity also stressed for safe human consumption of drugs. These two parameters i.e. quality and quantity are well confirmed in various types of bulk and commercial Pharma products by using different analytical techniques starting from oldest titrimetric analytical techniques to recently developed hyphenated techniques. A stability indicating analytical methods has been developed and validated for Delamanid as per International Conference on Harmonization. The Delamanid standard was exposed to acid and alkaline hydrolysis, oxidation, photolytic and thermal degradation conditionand separated using reversed phase BDS Hypersil C18 Column (250 × 4.6 mm, 5 μ; SN:10818991) , Mobile Phase: Acetonitrile: Water (80:20 v/v),Flow Rate: 1 ml/min, Column Temperature: Ambient , PDA Detection at 248 nm RT (min): 3.468 Asymmetry: 1.08 Plates (N): 3548. This method was validated for linearity, precision, accuracy, ruggedness and robusteness. Results obtained after validation study indicating that the proposed single method allowed analysis of Delamanid in the presence of their degradation products formed under a variety of stress conditions.

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