PRESERVATIVE PRECISION: A NOVEL UV METHOD FOR METHYL PARABEN QUANTIFICATION IN DRUG FORMULATIONS
DOI:
https://doi.org/10.55197/qjmhs.v4i1.135Keywords:
methyl paraben, UV spectrophotometry, pharmaceutical preservatives, method validation, quality control, FDA safety limitsAbstract
A simple, precise, and sensitive UV spectrophotometric method was developed and validated for the quantitative determination of methyl paraben in pharmaceutical formulations. The method utilized methanol as a solvent, with methyl paraben exhibiting maximum absorption at 256 nm. The linearity range was established as 1-5 µg/mL, with a correlation coefficient of 0.999. Method validation was performed according to ICH guidelines, demonstrating acceptable precision, accuracy, and sensitivity. The limits of detection and quantification were determined to be 0.071 µg/mL and 0.2154 µg/mL, respectively. The validated method was successfully applied to analyze methyl paraben content in three commercial pharmaceutical products: Clindamycin phosphate gel USP, Ketoconazole cream 2% w/w, and Luliconazole cream. Results confirmed that the methyl paraben content in all tested products complied with their respective label claims and fell within the FDA-approved safety limit of 0.015-0.2% for pharmaceutical formulations. This method offers a rapid and reliable approach for routine quality control analysis of methyl paraben in pharmaceutical products, ensuring compliance with regulatory standards and product safety.
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