A simple, rapid, and specific reversed-phase HPLC method has been developed for simultaneous analysis of withaferin-A and 6-gingerol in a polyherbal formulation containing Withania somnifera and Zingiber officinalis extracts. HPLC analysis was performed on a C 18 column using a 40:60 (v/v) mixture of acetonitrile and water as isocratic mobile phase at a flow rate of 1.5 mL min −1 . UV detection was at 227 nm for withaferin-A and 278 nm for 6-gingerol. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with International Conference on Harmonization guidelines. Validation revealed the method is specific, accurate, precise, reliable and reproducible. Good linear correlation coefficients (r 2 > 0.9996) were obtained for calibration plots in the ranges tested. Limits of detection were 0.2 and 0.4 μg and limits of quantification were 0.5 and 1.0 μg for withaferin-A and 6-gingerol, respectively. Intra and inter-day RSD of retention times and peak areas were less than 2.1%. Recovery was between 94.5 and 98.8% for withaferin-A and 94.2 and 102.4% for 6-gingerol. The established HPLC method is appropriate and the two markers are well resolved, enabling efficient quantitative analysis of withaferin-A and 6-gingerol. The method was successfully used for quantitative analysis of these two marker constituents in a marketed polyherbal formulation.
The study describes a validated stability indicating reverse-phase HPLC method for the estimation of tolperisone in bulk and in tablet formulation. The proposed RP-HPLC method utilizes a Hypersil C18 column (250 × 4.6 mm, 5 μm), optimum mobile phase consisted of methanol: acetonitrile: water (containing triethylamine 1% V/V) in the ratio of (85:10:5 V/V/V), effluent flow rate was kept at 1.0 mL/min and UV detection wavelength 250 nm. Tolperisone was exposed to various hydrolytic, thermal, photolytic and oxidative stress conditions, and the stressed samples were analysed by proposed method. The drug showed degradation under alkali and neutral hydrolysis and oxidative stress conditions. The degradation products were well resolved from the drug and demonstrated that the method is specific stability indicating for assay of tolperisone in presence of degradation products. The developed method was validated for linearity, accuracy, precision, robustness, ruggedness and specificity.
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