ABSTRACT

In areas like formulation creation, manufacturing, and packaging where data on substance conduct may be used to enhance a pharmaceutical item, forced degradation investigations may aid in promoting drug improvement. Therefore, it's crucial to understand how a medicine ingredient behaves under distinct natural circumstances. Stress Testing or Forced degradation is defined as the stability testing of drug substance and drug products under conditions exceeding those used for accelerated testing. It is an integral part of the information provided to regulatory authorities in registration application dossiers [ICH Q1 A (R2)]. To investigate stability related properties of an API and to develop an understanding of degradant. This studyhelps in safety toxicological, identification of possible genotoxic degradant and identification of potential metabolites and API designal discovery, determination of degradation pathway of drug substances and products; Structure elucidation of degradation products; The procedure has been evaluated for the Linearity (r2=0.9994), Precision and System suitability %RSD was not more than 2%, in order to ascertain the suitability of analytical method. It has been proved that the method is selective and linear between concentration range 10 – 50 ?g/ml for Mupirocin. In LOD and LOQ, signal-to-noise ratio found to be 0.10 and 0.30 respectively within given limit. In the Forced Degradation study various stress condition applied as, Acid Hydrolysis-Drug recovery 89.50 %. Base Hydrolysis- Drug recovery 71.08 %, Oxidative Hydrolysis – Drug recovery 58.04 % and in case of Photo-degradation, Neutral degradation there is 100% Drug recovery was found in API of Mupirocin. According to LC-MS data Mupirocin was unstable in acidic, alkaline and oxidative media but stable in neutral and photolytic condition Therefore, this method is validated as per ICH guidelines. Keywords: Stress degradation, Mupirocin, Chromatograph, Accuracy, Precision, and Stability
Publication date: 01/07/2025

https://ijbpas.com/pdf/2025/July/MS_IJBPAS_2025_9203.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.7.9203