Development of quality control parameters for classical ayurvedic formulation: Vyoshadi Churna

Abstract

Introduction: Ayurvedic formulations have a long history of use and have increased amazingly to follow the global interest in natural products. However, for many classical ayurvedic formulations, no quality parameters of standardization are available. Vyoshadi Churna, a classical Ayurvedic polyherbal formulation that cures indigestion and diarrhea, is being used since ancient times. However, there is no standard method available for its formulation and evaluation. Hence, the current study aims to develop the quality standards for Vyoshadi churna. Methods: The standard procedures for preparation and standardization of Churna described in Ayurvedic Pharmacopoeia of India (API) were used in the present study. Standardization includes pharmacognostical, chromatographic, and physico-chemical studies. The other essential studies were also done in accordance to API and World Health Organization guidelines to find the limits of microbial load, aflatoxin, heavy metals, and pesticide residue using modern analytical techniques such as gas chromatography-mass spectroscopy (MS) and inductively coupled plasma-MS/MS. Results: Vyoshadi Churna is of brown color and bitter in taste. Pharmacognostical studies have shown the characteristic features of almost each contributory crude drug. A unique chemical profile was also developed using toluene: ethyl acetate: methanol: formic acid (4:4:1:0.5) as the mobile phase to resolve maximum components. Furthermore, the standardized limits for the physicochemical studies, microbial load, heavy metals, aflatoxins, and pesticide residues were established and found in limits. Conclusion: This is for the first time when the standard operating procedure of Vyoshadi Churna was developed. Hence, the current technical work would be practically helpful for the future preparation and standardization study of Vyoshadi Churna.

Keywords

• gas chromatography-mass spectroscopy
• inductively coupled plasma-mass spectrometry/mass spectrometry
• quality control
• standard operating procedures
• standardization
• thin-layer chromatography
• vyoshadi churna