Analytical Procedure for determination and statistical validation of novel drug Mafenide acetate in pharmaceutical formulations

Abstract

Requirement for a sophisticated analytical method using HPLC and HPTLC is in high demand to meet the needs of a small scale industry for analysis of drugs that are relatively expensive. Hence a simple method was proposed in the routine determination of Mafenide acetate in pharmaceutical formulations and bulk dosage forms that can be less expensive. An analytical method was developed for the estimation of Mafenide acetate drug substance by liquid chromatography. The chromatographic separation was achieved on phenyl column (Eclipse XDB-Phenyl 250*4.6, 5um) at ambient temperature. The separation was achieved employing a mobile phase consisting of 0.1 %v/v Trifluoroacetic acid in water: Methanol (10:90). The flow rate was 1.0 ml/ minute and ultraviolet detector at 245nm. The average retention time for Mafenide acetate was 3.3 minutes. The proposed method was validated for selectivity, precision, linearity and accuracy. All validation parameters were checked and are found within the acceptable range. The assay methods were found to be linear ranging from 50-150 µg/ml for Mafenide acetate. The parameters considered for the procedure are related limit, selectivity, linearity, range, accuracy and precision are defined. Thesample solution leads to unequivocal, absolute identification of the analyte peak of interest apart from all other matrix components. The objective of our work is to form a basis for production procedure and control, which are designed to assure that the drug products have the identity, Quality, and purity. The results obtained could be treated as simple, sensitive and reproducible for determination of Mafenide acetate in pharmaceutical formulations.