Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF DESONIDE IN PRESENCE OF SORBIC ACID

Mayurkumar D. Jadav*, Dr. Ankit B. Chaudhary and Charmy D. Pandya

ABSTRACT

simple, rapid, economical, precise and accurate reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of Desonide in presence of Sorbic acid for their combined dosage form has been developed. The separation was achieved by C18 Thermo (250 x 4.6 mm, 5 μm) column and Methanol: Acetonitrile: Water (70:08:22) at pH 3.0 as mobile phase, at a flow rate of 1 ml/min and the effluent was monitored at 240 nm using DAD detector. Retention time of Sorbic Acid and Desonide were found to be 3.471 min and 4.592 min, respectively. The method was validated in terms of linearity, precision, accuracy and specificity, limit of detection and limit of quantization. Linearity of the Desonide and Sorbic Acid were in range of 10 – 30 μg/ml and 35 - 105 μg/ml respectively. The percentage assays of two drugs were found to be 100.27% and 100.23% for Desonide and Sorbic Acid respectively from the cream formulation. Repeatability, Intra-day and Inter-day Precision obtained for Desonide and Sorbic Acid in the range of 0.25 – 1.12% and 0.68 – 0.88% RSD for intra-day and 0.35 – 1.13% and 0.23 – 0.76% RSD for inter day and 0.49 and 0.50% RSD for repeatability. The method was found to be precise, accurate and specific during the study. The proposed method enables rapid quantification and simultaneous analysis of two drugs from commercial formulations without any excipients interference. The method can be used for routine analysis of marketed products of Desonide and Sorbic Acid in combined cream formulation.

Keywords: Reverse Phase High Performance Liquid Chromatography Method, Infra-Red Spectroscopy Method, Desonide, Sorbic Acid.