Evaluation of shelf-life study and qualitative, quantitative estimation of azadirachtin and nimbin in Ayush NT Capsule used in skin ailments

BACKGROUND: Ayurveda is an ancient science originating from the Indian subcontinent and helps keep the human body fit while providing cures from indigenous plants, animals, and mineral-origin products for various ailments. Ayurvedic products have an important role in disease prevention and treatment through the enhancement of antioxidant activity, inhibition of bacterial growth, and modulation of genetic pathways. Neem oil has multiple benefits, as per Ayurveda, and Ayurvedic formulations derived from Neem can be used for treating skin ailments. Literature reviews show that it has dermatological effects on the skin. METHODS: Ayurvedic capsule formulation with its major ingredient Neem oil shows that the R f values of reference standards azadirachtin and nimbin at 0.14 and at 0.59, respectively, were visible in the test solution of Neem oil and the Ayurvedic capsule formulation solution, which is also comparable after derivatizing under white light at 540 nm. The quantitative evaluation carried out by using high-performance liquid chromatography (HPLC) shows that the percentages of azadirachtin and nimbin present in the Neem oil were 0.0306% and 1.6134% respectively, while those in the Ayurvedic capsule formulation were 3.1523% and 3.7407%, respectively. RESULTS: Shelf-life study is an important tool in Ayurvedic formulations for the longer duration of finished pharmaceutical products. Shelf-life studies of this formulation from the Zero day to 11th quarter shows no variation in the analysis. Heavy metals were not detected. Pesticide residue, microbial load, and aflatoxins were detected below the detection limit. CONCLUSION: Standardization plays an important role in confirming the authenticity of any drug. The therapeutic role of Neem plant in disease management is still being enthusiastically researched due to the presence of few side effects and affordable properties. This article provides the data regarding standardization and shelf-life studies of Ayurvedic capsule formulation derived from Neem .