Abstract

FORMULATION DEVELOPMENT AND VALIDATION OF HERBAL CREAM CONTAINING DARUHARIDRA BY HPTLC

Unmesh Keshwar*, Anuradha Keshwar, Vinay Wagh, S.S. Dhurde, B.K. Shrikhande

ABSTRACT

The aim of this study was to formulate cream containing Daruharidra and to standardize it by HPTLC using pure berberine hydrochloride as a bioactive chemical marker. Cream was developed by incorporating Berberis aristata in a cream base by o/w emulsification technique. A new and simple HPTLC method was developed and validated for the quantitative estimation of berberine hydrochloride in herbal cream. Chromatography was performed on silica gel 60 F254 TLC plate using n- Butanol: Ethyl acetate: Glacial acetic acid: Water (3:5:1:1 v/v/v/v) as solvent system. Densitometry scanning was performed under reflectance-absorbance mode at 366 nm to quantify the spots. The Rf value of berberine hydrochloride was found to be 0.14 ± 0.02. The linear regression analysis data for calibration plots showed good linear relationship (r2 = 0.997) in the concentration range of 51 - 408 ng/spot. The content of berberine hydrochloride in formulated cream was found to be 0.0089 %. According to the ICH guideline the method was validate for accuracy, precision, recovery, robustness and ruggedness. The proposed method is simple and sensitive and can be used for the routine assay of berberine hydrochloride from various herbal cream formulations without interference of other herbal ingredients and excipients.

Keywords: HPTLC, Berberine hydrochloride, herbal cream, Daruharidra, Berberis aristata.