Abstract

DEVELOPMENT AND VALIDATION OF AMYLMETACRESOL BY RPHPLC METHOD AND QBD APPROACH

Poonam P. Waykar* and Rohit J. Bhor

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Abstract

Amylmetacresol (AMC), a widely used antiseptic in throat lozenges, requires precise measurement to ensure quality and efficacy in pharmaceutical formulations. This review focuses on the development and validation of an RP-HPLC method for quantifying AMC, employing a Quality by Design (QbD) approach. The QbD framework emphasizes identifying Critical Quality Attributes (CQAs) and establishing a robust Design Space through systematic risk assessment techniques, such as Failure Mode and Effects Analysis (FMEA). The RP-HPLC method was optimized for chromatographic conditions, including column selection, mobile phase composition, and flow rate, ensuring high sensitivity and specificity. Validation parameters such as linearity, precision, accuracy, and specificity were rigorously evaluated according to ICH guidelines. The method demonstrated excellent linearity with R² values exceeding 0.99, precision with relative standard deviations below 2%, and accuracy within the acceptable recovery range of 98-102%. Furthermore, the study highlights the importance of employing statistical tools for optimization and the need for ongoing stability studies to assess AMC's integrity under various conditions. By integrating QbD principles into the analytical method development process, this work contributes to enhanced quality assurance in the production of AMC-containing formulations, ultimately ensuring consumer safety and regulatory compliance. The findings underscore the potential for RP-HPLC combined with QbD to improve pharmaceutical analysis and facilitate the reliable delivery of therapeutic products.

Keywords: Amylmetacresol, RP-HPLC, QbD, AMC, Method development, Pharmaceutical.