School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, India.
Deparment of Pharmacy, Government Polytechnic College, Amritsar, Punjab, India.
Assay Drug Dev Technol. 2020 Aug/Sep;18(6):274-281. doi: 10.1089/adt.2020.983. Epub 2020 Jun 29.
Fisetin (FS) is a polyphenolic phytoconstituent reported to have various pharmacological activities such as antioxidant, antiparkinsonian, and antidepressant. An analytical method was developed and validated for the estimation of FS by ultrafast liquid chromatography using C-18 reverse phase column. Acetonitrile and orthophosphoric acid (0.2% v/v) in the ratio of 30:70 v/v was used as mobile phase. Flow rate was set at 1 mL/min. Chromatogram of FS was detected at wavelength of 362 nm. Retention time for FS was found to be 7.06 min. The developed method was found to be linear in the range of 2-10 μg/mL with regression coefficient of 0.9985. The method was validated as per the International Conference on Harmonization (ICH) Q2 (R1) guidelines. The percentage recovery was in the range of 95%-105%, which indicated the accuracy of the method. The percentage relative standard deviation (RSD) was found to be <2%, which indicates the precision of the method. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.46 and 1.41 μg/mL, respectively. The developed method was found to be robust as there was no significant change in response with change in flow rate, ratio of mobile phase, and pH. The method was successfully applied for estimation of drug loading and drug release from self-nanoemulsifying drug delivery system (SNEDDS). The % drug loading of FS in prepared liquid SNEDDS formulation was found to be 101.95%. The results of dissolution studies indicated 67.78% FS release in water at the end of 60 min.
非瑟酮（FS）是一种多酚类植物成分，据报道具有多种药理活性，如抗氧化、抗帕金森和抗抑郁作用。建立了一种用超快速液相色谱法测定 FS 的分析方法，采用 C-18 反相柱。以 30:70（v/v）的乙腈-0.2%（v/v）磷酸为流动相。流速设定为 1ml/min。FS 的色谱图在 362nm 处检测。FS 的保留时间为 7.06min。发现该方法在 2-10μg/ml 范围内呈线性，回归系数为 0.9985。该方法按照国际人用药品注册技术协调会（ICH）Q2（R1）指南进行了验证。回收率在 95%-105%范围内，表明方法的准确性。相对标准偏差（RSD）的百分比小于 2%，表明方法的精密度。检测限（LOD）和定量限（LOQ）分别为 0.46 和 1.41μg/ml。该方法被发现具有稳健性，因为在改变流速、流动相比例和 pH 值时，响应没有显著变化。该方法成功地应用于自乳化药物传递系统（SNEDDS）的载药量和药物释放的测定。制备的液体 SNEDDS 制剂中 FS 的载药量为 101.95%。溶出度研究结果表明，60 分钟时水中 FS 的释放量为 67.78%。
