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

Pharmaceutical Science-Pharmaceutical analysis for Novel drug formulation

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.