Standardization of classical ayurvedic dosage formulations of high market value

Abstract

In the present study from the traditional Vati preparations three renowned guggulu based vati preparations viz. Triphala guggulu, Kaishora guggulu and Gokshuradi guggulu have been studied and standardized.In the present study in addition to macroscopy and microscopy, physicochemical evaluation was also carried out. Further, shodhana of guggul was performed with different processing aids, but foreseeing the commercial aspects of manufacturing Triphala Kwath was considered for shodhana was made into a free flowing powder using spray dryer. By application of modern pharmaceutical processes to these three traditional formulae, unique tablet dosage forms with commercial feasibility have been developed. These newly developed dosage forms were evaluated for their properties as per USP. Further, from these formulations Triphala guggulu preparation was standardized by newly developed and validated High performance liquid chromatography (HPLC) method with markers viz. gallic acid, piperine and guggulsterones. Similarly, HPLC method has also been developed and validated for quantification of piperine, guggulsterones and embelin in Kaishora guggulu. In case of Gokshuradi guggulu, along with guggulsterones, tribulosin was also used for HPLC standardization in addition to gravimetric quantification of saponins.These newly methods were also used to evaluate some of the commercial preparations. The three guggul preparations were successfully demonstrated for their mass commercial production using industrial or industrially scalable equipments. These products were evaluated for quality parameters so as to meet modern regulatory perspective. Also these preparations were for the first times were standardized using hyphenated techniques like LC-MS for their quality control. Use of modern practice of pharmaceutical manufacturing, and quality control can also be applied to other vati preparations.