ISSN : 2663-2187

Development and Validation of a High-Performance Thin Layer Chromatography Method for Estimation of Polmacoxib in Pharmaceutical Bulk Form

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Krishna Kar, Bhavisha Patel
» doi: 10.33472/AFJBS.6.6.2024.1922-1936

Abstract

The present research outlines the development and validation of a method for the quantitative and qualitative analysis of Polmacoxib in bulk using High-Performance Thin Layer Chromatography (HPTLC). The study focuses on establishing a reliable and accurate analytical procedure to determine the concentration of Polmacoxib, ensuring its quality and adherence to regulatory standards. The method was successfully developed by employing TLC aluminium plates pre-coated with silica gel 60 F254 and CAMAG twin through chamber, the study optimized Toluene: Ethyl Acetate: Methanol (8:2:1 v/v/v) as mobile phase for efficient plate development at room temperature (25 ± 2°C). Utilizing CAMAG TLC scanner 4 with visionCATS user software, scanning and densitometric analysis were carried out at 322 nm (λ max), revealing sharp peaks and dense bands with an Rf value of 0.44. The developed method undergoes rigorous validation in adherence to ICH guidelines Q2 (R1), encompassing specificity, linearity, precision, LOD and LOQ, accuracy and robustness. The Linearity studies demonstrated a strong correlation (R2=0.9919) across the concentration range of 5-30 ng/spot. The precision results met the acceptance criteria, and LOD & LOQ were determined at 700.03 ng/spot and 2100.30 ng/spot, respectively. The recovery studies showed accurate results with RSD of 99.97%. Robustness testing involved deliberate changes confirming the method’s suitability for routine analysis. This validated HPTLC method establishes itself as a reliable analytical tool for the routine quantification of Polmacoxib, offering pharmaceutical researchers and technicians a practical and accurate approach. The results of this study contribute significantly to the qualitative and quantitative analysis of Polmacoxib in both bulk and pharmaceutical formulations, providing a robust foundation for quality control processes in the pharmaceutical industry.

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