Preservative Precision: a Novel Uv Method for Methyl Paraben Quantification in Drug Formulations
Year: 2025
Type: article
Abstract: 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.
Authors: ARAVINDH AKSHAYAA, VAIBHAV GUPTA
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: hybrid
OpenAlex ID: W4408764224