Drug Dissolution Studies and Determination of Deflazacort in Pharmaceutical Formulations and Human Serum Samples by RP‐HPLC#

Abstract

A simple, sensitive, reproducible, and validated RP‐HPLC method with UV detection is described for the determination of deflazacort in raw material, pharmaceuticals, human serum samples, and in‐vitro drug dissolution studies. The separation was achieved using a C18 (250 × 4.6 mm; 5 µm) column and a mobile phase comprising acetonitrile, methanol, and 0.067 M KH2PO4 in the ratio (27:20:53, v/v/v), adjusted to pH 6.5 with 3 M NaOH. The results of analysis were treated statistically and it has been validated and proven to be rugged. The limit of detection and limit of quantification were found as 2.05 ng mL−1 and 6.83 ng mL−1 in mobile phase and 4.06 ng mL−1 and 13.55 ng mL−1 in human serum samples, respectively. The method produced linear response in the concentration ranges 10–30,000 ng mL−1 in mobile phase and 25–30,000 ng mL−1 in serum samples. The intra‐ and inter‐day assay precision of the method was within 0.92% relative standard deviations in mobile phase and 1.48% relative standard deviations in human serum samples. This method was successfully applied for the determination of the drug in tablet dosage form, human serum, and drug dissolution studies. The results were found to be accurate, reproducible, and free from interference from the excipients or endogenous substance. #Presented at 3rd Agean Analytical Chemistry Days, September 29–October 3, 2002, Levos, Greece.