Development and Validation of RP-HPLC Method for Simultaneous Estimation of Three Components in cream formulation used in Hemorrhoids Disease

Developing a single analytical method for determination of individual drug from a multidrug composition is a very difficult task. The present work describes a simple, rapid, precise reverse phase chromatographic method that has been developed and validated for simultaneous estimation of multicomponent cream formulation containing Lignocaine HCl, Beclomethasone dipropionate and Phenylepherine HCl. The estimation was carried out on Hypersil BDS C18 (5 µm × 25 cm × 4.6 mm i.d.) column using a mixture of ammonium acetate buffer pH 5.0 and methanol in the ratio 60:40(v/v) as a mobile phase, at a flow rate of 1.0 ml/min and detection was performed at 222 nm. Three drugs Lignocaine HCl, Beclomethasone dipropionate and Phenylepherine HCl were eluted at the retention times of 3.3 min, 4.1 min and 11.49 min, respectively. The method was validated for accuracy, precision, linearity, specificity and sensitivity as per ICH guideline. The validated method is a rapid and cost effective and successfully applied to the commercially available pharmaceutical dosage form, yielding very good and reproducible result.