Quality Evaluation and Standardization of An Ayurvedic Formulation Bilvadileha: A Bioanalytical Approach

Abstract

Bilvadileha; an Ayurvedic semi-solid formulation, is prescribed for the treatment of digestive impairment, tastelessness, emesis and excessive salivation. Though the formula composition and therapeutic claims of Bilvadileha are part of the Ayurvedic Formulary of India, the scientific methods for its quality and safety evaluation are yet to be documented. Hence, in the current work an attempt has been made to evaluate the quality parameters to be used for its preparation and processing. Standard operating procedure for the preparation of Bilvadileha was developed by the amalgamation of traditional methods and scientific tools. Preliminary phytochemicals in Bilvadileha were qualitatively estimated along with determination of crude fibre and reducing sugar content. Chromatographic standardization of Bilvadileha was carried out using HPTLC which included the determination of piperine content in Bilvadileha along with the evaluation of its stability samples stored for different storage periods. Safety of the formulation was affirmed in mice by carrying out acute toxicity study. The quality control parameters resulted after scientific evaluation of Bilvadileha can be used as reference standards by quality control/assurance unit of a pharmaceutical firm in order to have a proper quality check over its preparation and processing.