Patel Archita, Macwana Chhaya, Parmar Vishal, Patel Samir
Kadi Sarva Vishwavidyalaya, Gandhinagar, Gujarat, India.
J AOAC Int. 2012 Mar-Apr;95(2):419-23. doi: 10.5740/jaoacint.1-095.
An accurate, simple, reproducible, and sensitive HPLC method was developed and validated for the simultaneous determination of atorvastatin calcium, ezetimibe, and fenofibrate in a tablet formulation. The analyses were performed on an RP C18 column, 150 x 4.60 mm id, 5 pm particle size. The mobile phase methanol-acetonitrile-water (76 + 13 + 11, v/v/v), was pumped at a constant flow rate of 1 mL/min. UV detection was performed at 253 nm. Retention times of atorvastatin calcium, ezetimibe, and fenofibrate were found to be 2.25, 3.68, and 6.41 min, respectively. The method was validated in terms of linearity, precision, accuracy, LOD, LOQ, and robustness. The response was linear in the range 2-10 microg/mL (r2 = 0.998) for atorvastatin calcium, 2-10 microg/mL (r2 = 0.998) for ezetimibe, and 40-120 microg/mL (r2 = 0.998) for fenofibrate. The developed method can be used for routine quality analysis of the drugs in the tablet formulation.
建立了一种准确、简单、可重复且灵敏的高效液相色谱法，用于同时测定片剂制剂中阿托伐他汀钙、依折麦布和非诺贝特的含量，并进行了方法验证。分析在反相C18柱（150×4.60 mm内径，5μm粒径）上进行。流动相为甲醇 - 乙腈 - 水（76 + 13 + 11，v/v/v），以1 mL/min的恒定流速泵入。在253 nm处进行紫外检测。阿托伐他汀钙、依折麦布和非诺贝特的保留时间分别为2.25、3.68和6.41分钟。该方法在线性、精密度、准确度、检测限、定量限和稳健性方面进行了验证。阿托伐他汀钙在2 - 10μg/mL范围内响应呈线性（r2 = 0.998），依折麦布在2 - 10μg/mL范围内响应呈线性（r2 = 0.998），非诺贝特在40 - 120μg/mL范围内响应呈线性（r2 = 0.998）。所建立的方法可用于该片剂制剂中药物的常规质量分析。
