背景:JatyadiTaila(JT)是一种著名的阿育吠陀伤口愈合产品,包括16种不同的药用重要植物,包括姜黄,Terminaliachebula,还有茉莉.
目的:拟议的工作讨论了绿色和经济稳定性指示HPTLC方法的开发和验证,该方法用于定量关键标记植物成分;姜黄素(CUR),没食子酸(GA),和熊果酸(UA)来自JatyadiTaila(JT)。
方法:按照标准程序测定JT的质量标准参数。标记成分CUR,GA,使用甲苯:乙酸乙酯:甲酸(6:2:1,%v/v/v)作为流动相从JT中拆分和UA,随后衍生化以估计UA。对显影的板进行HPTLC-MS分析。对所有成分进行强制降解,以确定所提出的技术的稳定性指示性能以及市售制剂和标记成分的加速稳定性研究。该方法的绿色度评估由AGREE方法辅助。
结果:CUR的Rf值,GA,和UA分别为0.60和0.60;0.27和0.28;参考标准和油样分别为0.74和0.77,在366nm分析时,290nm,和366nm分别。进行HPTLC-MS以验证JT中存在的活性成分。成分遵循一级降解动力学。CUR的数量,GA,在加速稳定性研究结束时,JT中的UA降低。所开发的方法经验证符合ICHQ2(R2)指南。
结论:在选定的关键标记中,GA在强制降解过程中高度不稳定。JT应使用更多保护性包装材料在受控温度下储存,以确保其质量和功效。
结论:开发的方法可用作JT的质量控制工具,因为它可用于确定草药制剂中关键标记化合物的稳定性。
BACKGROUND: Jatyadi taila (JT) is a well-known Ayurvedic wound-healing product, comprising 16 different medicinally important plants, including Curcuma longa, Terminalia chebula, and Jasminum officinale.
OBJECTIVE: The proposed work discusses the development and validation of the green and economical stability-indicating HPTLC method for quantification of the key marker phytoconstituents, curcumin (CUR), gallic acid (GA), and ursolic acid (UA), from JT.
METHODS: Quality standard parameters for JT were determined following standard procedures. The marker constituents CUR, GA, and UA were resolved from JT using toluene-ethyl acetate-formic acid (6:2:1, v/v/v) as the mobile phase and subsequently derivatized to estimate UA. The developed plates were subjected to HPTLC-MS analysis. All constituents were subjected to forced degradation to determine the proposed technique\'s stability-indicating property and the accelerated stability studies of marketed formulation and marker constituents. Greenness evaluation of the method was aided by the AGREE methodology.
RESULTS: The Rf values of CUR, GA, and UA were found to be 0.60 and 0.60; 0.27 and 0.28; and 0.74 and 0.77 from reference standard and oil samples respectively, when analyzed at 366 nm, 290 nm, and 366 nm, respectively. HPTLC-MS was carried out to verify the active constituents present in JT. The constituents followed first-order degradation kinetics. The quantity of CUR, GA, and UA in JT was reduced at the end of accelerated stability studies. The developed approach was validated in compliance with the International Conference on Harmonization (ICH) Q2 (R2) guideline.
CONCLUSIONS: Among the chosen key markers, GA was highly unstable during forced degradation. JT should be stored at a controlled temperature using more protective packaging material to ensure its quality and efficacy.
CONCLUSIONS: The developed method can be used as a quality control tool for JT as it can be used to determine the stability of the key marker compounds the herbal formulation.