Analytical methodology for novel film forming mafenide spray: Assay and Drug excipient compatibility study by HPLC-PDA

Abstract

Abstract This paper describes the short, precise, and accurate reverse-phase HPLC method for quantifying mafenide in the final product of a film-forming spray formulation. Further, the method is validated per the International Council for Harmonization (ICH) guidelines. The chromatographic separation of the formulation was achieved using mobile phase A as 10 mM potassium dihydrogen phosphate (KH2PO4) and mobile phase B as methanol (HPLC grade) in the ratio of 85:15 V/V. Several columns were screened, and finally, InertSustain C8 (4.6 x 250 mm), spherical 5µm particle size, was chosen for the final method. The chromatography was carried at ambient room temperature with a flow rate of 0.8 mL/min. For the detection of the analyte, 222 nm (λmax) was selected after scanning the sample in the PDA detector. The developed method was linear in the range of 5 ppm to 25 ppm of mafenide. The method proposed here has an excellent regression coefficient (R2) of 0.9995 with a precision of results less than 2% RSD. The percentage recovery values and assay readings of 98–102% were achieved. The LOD of the method developed was found to be 19 ng/mL, and the LOQ determined was 58 ng/mL. The study was further extended to know any Drug-Excipient interaction to prove that there is no interference between the excipients and Mafenide hydrochloride in a spray formulation.