Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF BECLOMETHASONE DIPROPIONATE, PHENYLEPHRINE HYDROCHLORIDE AND LIGNOCAINE HYDROCHLORIDE IN CREAM

Deveshkumar M. Patel*, Ankit B. Chaudhary and Bhoomi D. Patel

ABSTRACT

A simple, rapid, economical, precise and accurate RP-HPLC method for simultaneous estimation of PHE, LIG and BEC in their combined dosage form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of PHE, LIG and BEC in their combined dosage form has been developed. The separation was achieved by Inertsil ODS C18 column (250 x 4.6 mm,5μm) column and Water (pH 4.0): Methanol (70:30) as mobile phase, at a flow rate of 1 ml/min and the effluent was monitored at 240 nm using PDA detector. Retention time of PHE, LIG and BEC were found to be 4.653min, 5.603 min and 11.083 min, respectively. The method was validated in terms of linearity, precision, accuracy and specificity, limit of detection and limit of quantization. Linearity of the PHE, LIG and BEC were in range of 2 – 6 μg/ml, 50 – 150 μg/ml and 0.5 – 1.5 μg/ml respectively. The percentage assay of three the drugs were found to be 98.135%, 96.931% and 98.625% for PHE, LIG and BEC respectively from the cream formulation. Repeatability, Intra-day and Inter-day Precision obtained for PHE, LIG and BEC in the range of 0.167 – 0.532, 0.125 – 0.406 and 0.683 – 1.541% RSD for intra-day and 0.607 – 1.321, 0.579 – 1.034 and 0.554 – 0.902% RSD for inter day and 0.869, 0.778 and 0.924% 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 three drugs from commercial formulations without any excipients interference. The method can be used for routine analysis of marketed products of PHE, LIG and BEC in combined cream formulation.

Keywords: Reverse Phase High Performance Liquid Chromatography Method, Infra-Red Spectroscopy Method, Lignocaine HCl, Phenylephrine HCl, Beclomethasone Dipropionate.