Background Anu Taila is an ancient medicated oil Ayurvedic preparation that is commonly used for nasya karma. It contains more than 25 herbs and goat milk as per the Ayurvedic Formulary of India (AFI). It strengthens the neck, shoulder, and chest muscles and improves the capacity of sense organs. It delays the aging process and reduces hair fall. Recent studies showed that it is also useful in COVID-19. In the current study, an attempt to develop quality control protocols and evaluate the standardization parameters like refractive index, iodine value, saponification value, peroxide value, acid value, rancidity, HPTLC fingerprint profile along with major bioactive compound and quantification of Berberine chloride, Negundoside, and Marmelosin by HPLC. Establishing quality protocol and standard parameters like physicochemical parameters and estimation of bioactive compounds of this preparation is significant for quality control. Results In this study, HPTLC identifies bioactive chemical compounds like Berberine chloride, Marmelosin, Negundoside, glycyrrhizin, and para hydroxybenzoic acid (PHBA), Lupeol, Embelin, and Solasodine, which were present in the Anu Taila formulation. HPLC was used to estimate the bioactive marker compounds Negundoside, Berberine chloride, and Marmelosin were present in the Anu Taila formulation. The quantitative evaluation of Berberine chloride (0.0013%), Marmelosin (0.0366%), Negundoside (0.0086%) is present in Anu Taila formulation. Conclusion The study reveals that sufficient quality control parameters were followed during the preparation of the formulation. Physicochemical analysis was carried out as per the guidelines of Ayurvedic Pharmacopeia of India. HPTLC and HPLC profiles generated in this particular study can be considered as a preliminary tool ascertaining the authenticity of Anu Taila.

Standardization is an important measurement for ensuring the quality control of herbal drugs. It has become essential to develop reliable, specific and sensitive quality control methods. Ashwagandhadi lehyam is an important Ayurvedic formulation containing Withania somnifera L., as one of the prime ingredient of formulation. The present study was undertaken to develop standardization parameters for Ashwagandhadi lehyam. Evaluation of various standardization parameters like organoleptic characters, Physico-chemical evaluation, HPTLC finger print profiling along with dominant bioactive markers and estimation of bioactive markers Withaferin-A by HPLC. The R f value of Withaferin-A 0.35 and Withanolide-A 0.45 is in formulation and reference standards were found comparable under UV light at 254 nm and 540 nm. The HPLC chromatogram of Ashwagandhadi lehyam and standard Withaferin-A showed at Rt of 5.015 and 5.050 min. The percentage of Withaferin-A was 0.092% present in Ashwagandhadi lehyam formulation. Bioactive markers are characteristic to the ingredients or botanicals to identify the presence of ingredients in formulation easily. The presence of bioactive markers is possible and its verification through the HPTLC fingerprint profile and quantification of biomarker by HPLC are the best ways to identify evaluate the quality of the finished formulation in the course of development of a standardization protocol for quality control of Ayurvedic formulation.

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