ANALYTICAL METHOD DEVELOPMENT AND ITS VALIDATION FOR EVALUATION OF POLYHERBAL FORMULATION

摘要

Talekt capsule is a branded polyherbal formulation used for enhancing the immune response to dermal infections and also for treating skin disorders. Curcumin and embelin, which are the active constituents of Haridra and Vidanga, respectively were used as marker compounds for developing a simple, accurate, precise and robust HPTLC method for simultaneous estimation. The mobile phase of toluene: ethyl acetate: formic acid (6.5: 3: 0.2 V/V/V) was used for separation. 381 nm was used as wavelength for analysis. The R, value obtained for curcumin, and embelin was found to be 0.51 ± 0.2 and 0.33 ± 0.2, respectively. The developed method was validated on the basis of ICH Q2 (R1) guidelines. According to WHO guidelines, herbal products need to be standardized with respect to safety before releasing it into the market. Standardization assesses the quality of formulations on the basis of concentration of their active principles. Newer analytical techniques are used for quantitative and qualitative analysis of various drugs and formulations. The present study illustrates HPTLC method for evaluation of marketed formulation, Talekt capsules of established brand Himalaya Herbal Healthcare. It is a used for enhancing the immune response to dermal infections and also for treating skin disorders. It consists of eight ingredients namely: Haridra (powder of dried rhizome of Curcuma longa), Vidanga (extract of Embelia ribes), Aragvadha (powder of Cassia fistula), Nimba (extract of Azadirachta indica), Guduchi (extract of Tinospora cordifolia), Triphala extract, Bhringaraja (extract of Eclipta alba) and Yavatikla (extract of Andrographis paniculata). The active constituent curcumin of Haridra possesses anti-inflammatory, anti-allergic and anti-bacterial activity3. Embelin, which is the active constituent of Vidanga exerts anti-oxidant, analgesic, anti-tumor, anti-bacterial and anti-inflammatory activity. HPTLC method was developed for simultaneous estimation of curcumin and embelin.