HPTLC METHOD DEVELOPMENT AND VALIDATION FOR STANDARDIZATION OF AYURVEDIC FORMULATION: MAHASHANKH VATI

Ayurveda is the primeval complete serving system in medical field. However, one of the barriers in the acceptance of the Ayurvedic formulation is the paucity of standard quality control outline. World health organization (WHO) in 1999 has given a detail procedure for the standardization of herbal drugs comprising of a single content but not for standardization of polyherbal formulations. Mahashankhvati is official in Ayurvedic Formulary of India and is prescribed for treatment of haemorrhoids, malabsorption syndrome, dyspepsia and indigestion. In the proposed work, attempt has been made for standardization of Mahashankh Vati by developing chromatographic method. Piperine from Piper longum and Piper nigrum, Umbelliferone from Ferula asafoetida and Gallic acid from Terminaliachebula present in formulation were selected as marker compounds. A new, rapid, simple, precise, selective HPTLC method was developed for marketed preparation of Mahashankhvati. The separation was performed on TLC aluminium plates precoated with silica gel 60 F₂₅₄, using toluene: ethyl acetate: methanol: formic acid (7:2:2.5:0.5 v/v/v/v) as mobile phase. The densitometric analysis was carried out at the detection wavelength of 290 nm. The R_f values of piperine, umbelliferone and gallic acid was found to be 0.65, 0.52 and 0.32 respectively.The developed method has been validated as per ICH guidelines