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A rapid and simple high performance thin layer chromatographic method has been developed for the standardization and quantification of withanolide A from an herbal oral thin film (OTF). HPTLC profile was developed using Toluene: Ethyl acetate: Formic acid (8:4:0.6) as a mobile phase and evaluated on the basis of different parameters. The Rf values of withanolide A was found to be 0.23. The total peak areas of the withanolide A and the corresponding peak areas of different formulations were compared and withanolide A were estimated as 2.25mcg. The limit of detection and limit of quantification was found to be 30ng/spot and 80ng/spot. The percent recovery was found to be well within the limit of 98 to 102%.The present study rationalizes the use of different withanolide A formulations profiles for ascertaining the identity, purity and strength of the different withanolide A formulations and also for generating data which may be use in setting up of these herbal formulations by evaluating these formulations on the basis of various parameters. The method was found to be simple, reliable, accurate and precise in accordance with ICH guidelines.

Keywords

Ashwagandha, Withanolide A, OTF, Mouth Dissolving Film, Method Development, Validation, Densitometry, Quantification, Withanolide A and Chromatography

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