ABSTRACT
Aim: Pushyanuga churna (PC) is an Ayurvedic formulation composed of twenty-five plant ingredients and one mineral described in AFI for its use in various female reproductive disorders. Owing to its therapeutic efficacy, it is prepared and marketed by different manufacturers. But, as there is paucity of scientific data on its standardization and quality control parameters which may lead to undesired quality and variation in its consistency, standardization of this formulation using modern bioanalytical techniques is required. Material and Methods: Pushyanuga churna (PC) was purchased from the market, manufactured by different companies subjected to quality control parameters. HPTLC-fingerprint for different marketed of PC was developed. Further, a simple, rapid, accurate and sensitive HPTLC method was developed for the estimation of two therapeutically potent biomarkers viz. gallic acid and bergenin simultaneously using a toluene: ethyl acetate: methanol: formic acid as mobile phase. The developed method was validated as per ICH guidelines. Results and Discussion: Preliminary phytochemical, physicochemical analysis and chromatographic fingerprint for different manufacturers of Pushyanuga churna were established. It was observed that all the marketed samples did not show uniformity in results. Quantitation of two bioactive markers were evaluated and the maximum content of gallic acid and bergenin were found in marketed Pushyanuga churna 2 (2.346 ± 0.026 mg/g) and marketed Pushyanuga churna 4 (2.283 ± 0.175 mg/g) respectively. Conclusion: The data obtained from scientific evaluation of PC can be adapted to lay down new pharmacopoeial standards for batch-to-batch consistency. KEY WORDS: Bergenin, Gallic acid, High-performance thin-layer chromatography, Pushyanuga churna
… Ltd., Mumbai. Reference standards, gallic acid (≥98% purity) was procured from Sigma-Aldrich, Steinheim, Germany, and bergenin (≥97.0% purity) was procured from ChengduBiopurify Phytochemicals Ltd., China. 10% methanolic …
