Speaker
Description
Metamizole sodium monohydrate is a widely used non opioid analgesic and antipyretic, for which effective control of related substances is essential to ensure product quality. Although pharmacopoeial HPLC methods are established for this purpose, verification is required to confirm their suitability under routine laboratory conditions.
The aim of this study was to verify a pharmacopoeial HPLC method for the determination of related substances in metamizole sodium monohydrate. Method verification was performed in accordance with Ph. Eur. General Chapter 5.26, with evaluation of precision, specificity, and limit of quantification. Method precision was assessed using six independent samples, yielding a relative standard deviation (RSD) of the main peak area not exceeding 10 %. System precision, determined by six injections of the reference solution, demonstrated RSD ≤ 5%. Specificity was confirmed by chromatographic separation of the active substance from relative impurities with no observed interference at the retention time of the principal peak. The limit of quantification complied with the Ph. Eur. reporting shreshold, providing a signal-to-noise ratio of approximately 10:1 and acceptable precision (RSD ≤ 10 %).
The results of the verification study confirm that the pharmacopoeial HPLC method is suitable for its intended use in the routine quality control. This study supports reliable method implementation in quality control environment and contributes to compliance with pharmacopoeial and regulatory requirements for impurity profiling.
Keywords: Metamizole sodium monohydrate, specificity, precision, limit of quantification.
References:
1. European Pharmacopoeia Commission, European Pharmacopoeia, Council of Europe, Strasbourg, current edition: General Chapter 5.26, Verification of pharmacopoeial procedures.