Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF SWERTIAMARIN IN MARKETED PREPARATION CONTAINING ENICOSTEMMA LITTORALE

Jayshil A. Bhatt*, Rajeshwari Rathod, Vinod Jairaj and Ramesh K. Goyal

ABSTRACT

A high-performance liquid chromatographic method was developed and validated for the quantitative determination of swertiamarin antidiabetic drug that constitutes one of the biomarkers in Enicostemma littorale, a first line of regimens in antidiabetic herbal therapy. Different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and limit of quantification (LOQ) were determined according to International Conference on Harmonization ICH Q2B guidelines. Chromatography was carried out by isocratic technique on a reversed-phase Hiqsil C18 column with mobile phase based and optimized depending on the polarity of the molecules. The UV spectrophotometric determinations were performed at 238nm. The linearity of the calibration curves for analyte in the desired concentration range was good (r2 > 0.999) by the HPLC methods. The method was accurate and precise with recoveries in the range of 80 and 83% for the drug and relative standard deviation (R.S.D.) <5%. Moreover, the accuracy and precision obtained with HPLC can be a cheap, reliable and less time consuming alternative for Chromatographic analysis. The proposed method are highly sensitive, precise and accurate and hence were successfully applied for the reliable quantification of Poly herbal formulation containing swertiamarin.

Keywords: Swertiamarin, Enicostemma littorale, Antidianetic, Poly herbal, HPLC, UV Spectrophotometrics.