A NOVEL APPROACH FOR THE QUALITY ASSESSMENT AND STABILITY TESTING OF AYURVEDIC POLYHERBAL FORMULATIONS BY HPTLC FINGERPRINT METHOD

Ayurveda and herbal medicinal products contain a combination of botanicals; each of these contains number of chemical compounds that may give the anticipated activity in combination. Therefore, an analytical technique was developed that can be used to evaluate these compounds collectively and provide a more rational approach for quality control and stability in the study of Ayurvedic and polyherbal formulations. This study proposes determination of chemical stability of active/marker components by analyzing the HPTLC fingerprint of a polyherbal formulation as per ICH guidelines for tablet formulation containing kalmegh, kutki, and bhuiamla. The chemical stability of andrographolide, kutokoside, picroside-I, phyllanthin, and hypophyllanthin was performed at 30 +/- 2 degrees C and 65 +/- 5% RH, 40 +/- 2 degrees C, and 75 +/- 5% RH and at refrigeration temperature (5 +/- 1 degrees C) for initial, 1-, 2-, 3-, and 6-month interval. Chromatographic separation was achieved on precoated silica gel 60 F254 HPTLC plates using toluene: ethyl acetate: methanol: formic acid (24-21-6-3v/v/v/v) as a mobile phase. Fingerprint analyses were carried out at a wavelength of 254nm. The method exhibited adequate linearity, selectivity, and precision.