Tarek Mohamed, Wagdy Hebatallah A, Elzanfaly Eman S, Amer Sawsan M
Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt (BUE), Cairo 11837, Egypt.
The Center for Drug Research and Development (CDRD), Faculty of Pharmacy, The British University in Egypt, Cairo 11837, Egypt.
J Chromatogr Sci. 2020 Jan 17;57(10):867-873. doi: 10.1093/chromsci/bmz082.
Nadifloxacin, mometasone furoate and miconazole nitrate are formulated together as a topical antifungal dosage form. In this work, a reversed-phase ultra-performance liquid chromatographic method coupled with a diode array detector (RP-UPLC-DAD) was developed and validated to determine nadifloxacin, mometasone furoate and miconazole nitrate simultaneously in their bulk powder, in pharmaceutical preparation and in spiked human plasma samples. Separation was achieved on an ACQUITY UPLC C18 column of 2.2 μm particle size (2.1 × 100 mm) via isocratic elution using a mobile phase consisting of methanol, acetonitrile and water with ratio (50:20:30; v/v/v) and 0.1 g ammonium acetate, then pH was adjusted to (7.00) using acetic acid, flow rate 0.6 mL/min, temperature 30°C and UV detection at 220 nm. The method is linear in a range from 5 to 400 μg/mL for both nadifloxacin and miconazole nitrate and from 20 to 500 μg/mL for mometasone furoate. The method was validated according to the ICH guidelines then applied successfully to determine the mentioned drugs in their pharmaceutical preparation and spiked human plasma samples. For plasma samples, the results showed that the method can determine nadifloxacin, mometasone furoate and miconazole nitrate in human plasma samples with high accuracy and precision.
那氟沙星、糠酸莫米松和硝酸咪康唑被配制成一种局部用抗真菌剂型。在本研究中，开发并验证了一种反相超高效液相色谱法结合二极管阵列检测器（RP-UPLC-DAD），用于同时测定那氟沙星、糠酸莫米松和硝酸咪康唑在其原料药、药物制剂以及加标人血浆样品中的含量。使用粒径为2.2μm的ACQUITY UPLC C18柱（2.1×100mm），通过等度洗脱进行分离，流动相由甲醇、乙腈和水按比例（50:20:30；v/v/v）以及0.1g醋酸铵组成，然后用醋酸将pH值调至（7.00），流速为0.6mL/min，温度为30°C，在220nm处进行紫外检测。该方法对那氟沙星和硝酸咪康唑在5至400μg/mL范围内呈线性，对糠酸莫米松在20至500μg/mL范围内呈线性。该方法按照国际人用药品注册技术协调会（ICH）指南进行了验证，然后成功应用于测定药物制剂和加标人血浆样品中的上述药物。对于血浆样品，结果表明该方法能够高精度、高准确度地测定人血浆样品中的那氟沙星、糠酸莫米松和硝酸咪康唑。
