VALIDATED CHROMATOGRAPHIC METHODS FOR STANDARDIZATION OF RESTOBAL LIQUID – AN IMMUNOMODULATORY AND ANTI STRESS POLYHERBAL PRODUCT

Kotagiri Ravikanth, Deepak Thakur*, Anil Kanaujia, Anirudh Sharma and Uday Veer Singh Thakur

ABSTRACT

Standardization is the code of conduct in order to ensure the efficacy that manufacturers should use to ensure batch to batch consistency of the product. Efficient standardization and quality control of multi-herbal formulations can be achieved by adopting validated methods on the sophisticated instrument like HPLC and HPTLC. Standardization of the product Restobal liquid with respect to its phytotherapeutic constituents was undertaken wherein HPLC and HPTLC methods for Glycyrrhizin and Gallic acid estimation respectively were optimized and validated using the linearity, selectivity, precision, recovery, LOD & LOQ parameters in accordance with the statistical method of validation given in ICHQ2R1. The average recovery of (Glycyrrhizin) 98.68 % and (Gallic acid) 99.99 % were computed from the regression equation. RSD for inter-day and intra-day variability was also found to be less than 1%. The method thus developed is being successfully applied in identification and quantification of phytotherapeutic constituents.

Keywords: Standardization, Glycyrrhizin, Gallic acid, Restobal, HPLC, HPTLC.