Zeitschrift für Bioanalyse und Biomedizin

Spectrophotometric Determination of Sertaconazole Nitrate in Pharmaceutical Dosage Form using Quality by Design (QbD) Framework

Abstract

Sagar Suman Panda*, Sarwar Beg, Ravi kumar Venkata Varaha Bera and Aruneema Gain

An accurate and reliable ultra-violet spectrophotometric method was developed based on the Quality by Design framework, for the determination of sertaconazole nitrate in solid oral dosage form. Sampling interval and scanning speed were the two critical method variables, which were also evaluated by design of experiment approach, for establishing method robustness using optimization technique. Sertaconazole shows absorption maximums at 260 nm, 293 nm and 302 nm, respectively using methanol as solvent. Good linearity was obtained for sertaconazole over concentration of 10-60 μg/ml with R2 >0.99 at all the three wavelengths. The results of validation study were within acceptance limits as per ICH guidelines. The QbD instigated method for determination of sertaconazole nitrate can be highly effective for routine analysis purpose.