Development of quality control parameteres for standardisation of in house and marketed balarista formulations

Abstract

vi newlineABSTRACT newlineBalarista is an important ayurvedic fermented liquid formulation, prepared using newlinethe ingredients as mentioned in the ayurvedic pharmacopoeia of India (API). It contains newlinenot more than 10 percent and not less than 5 percent of alcohol that is self generated newlineduring the preparation over a period of time. The formulation is prescribed in various newlinediseased conditions such as; agnimandya (digestive impairment), daurbalya (weakness), newlinevataja roga (diseases due to vata dosa), karsya (emaciation), and also in the treatment of newlinerheumatism at a dose of 15 30 ml orally with equal amount of water, after meals, twice a newlineday. newlineThe formulations, available in the market, are usually not properly standardized, newlinewhich leads to safety and efficacy issues. Therefore, for a comparative quality newlineassessment study, an in-house Balarista (IBF) formulation was prepared according to the newlineAPI and four marketed formulations were procured from the local market, which were newlinecoded as M1, M2, M3, and M4. The quality control parameters of all drug ingredients newlineand the formulations were studied for their pharmacognostical, physico-chemical and newlineanalytical (FTIR, GC-MS, HPTLC, HPLC) profiles. The anti-arthritic potential of in- newlinehouse and marketed formulations was also assessed in Complete Freund s adjuvant newlinearthritic rats in order to justify its traditional use. newlineIn this study, Balarista was prepared using various medicinal plant parts and other newlineingredients such as; Sida cordifolia (L.) (root) and Withania somnifera (L. Dunal) (root), newlinewhich were considered as the prime drugs of the formulation along with the other newlineingredients such as; Saccharum officinarum L. (Jaggery), Woodfordia fruticosa L. Kurz newline(flower), Ipomoea digitata L. (sub root), Ricinus communis L. (root), Alpinia galanga L. newlineWilld (root), Elettaria cardamom L. Maton (seed), Paederia foetida L. (whole plant), newlineSyzygium aromaticum L. Merr. and L. M. Perry (flower bud), Vetiveria zizan newline