Nakarani Naresh V, Bhatt Kashyap K, Patel Rutva D, Bhatt Hemaxi S
A.R. College of Pharmacy, Vallabh Vidyanager - 388120, Dist. Anand, Gujarat, India.
J AOAC Int. 2007 May-Jun;90(3):700-5.
Two simple and accurate methods to determine atorvastatin calcium (ATO) and fenofibrate (FEN) in combined dosage forms were developed using second-derivative spectrophotometry and reversed-phase liquid chromatography (LC). ATO and FEN in combined preparations (tablets) were quantitated using the second-derivative responses at 245.64 nm for ATO and 289.56 nm for FEN in spectra of their solution in methanol. The calibration curves were linear [correlation coefficient (r) = 0.9992 for ATO and 0.9995 for FEN] in the concentration range of 3-15 microg/mL for ATO and FEN. In the LC method, analysis was performed on a Hypersil ODS-C18 column (250 mm x 4.6 mm id, 5 microm particle size) in the isocratic mode using the mobile phase methanol-water (90 + 10, v/v), adjusted to pH 5.5 with orthophosphoric acid, at a flow rate of 1 mL/min. Measurement was made at a wavelength of 246.72 nm. Both drugs were well resolved on the stationary phase, and the retention times were 1.95 min for ATO and 5.50 min for FEN. The calibration curves were linear (r = 0.9985 for ATO and 0.9976 for FEN) in the concentration range of 3-15 microg/mL for ATO and FEN. Both methods were validated, and the results were compared statistically. They were found to be accurate, precise, and specific. The methods were successfully applied to the estimation of ATO and FEN in combined tablet formulations.
采用二阶导数分光光度法和反相液相色谱法（LC）开发了两种简单准确的方法来测定复方制剂中的阿托伐他汀钙（ATO）和非诺贝特（FEN）。在甲醇溶液光谱中，利用ATO在245.64nm处和FEN在289.56nm处的二阶导数响应来定量复方制剂（片剂）中的ATO和FEN。校准曲线在ATO和FEN浓度范围为3 - 15μg/mL时呈线性[ATO的相关系数（r）= 0.9992，FEN的相关系数（r）= 0.9995]。在LC法中，分析在Hypersil ODS - C18柱（250mm×4.6mm内径，5μm粒径）上以等度模式进行，流动相为甲醇 - 水（90 + 10，v/v），用正磷酸调节至pH 5.5，流速为1mL/min。在波长246.72nm处进行测定。两种药物在固定相上分离良好，ATO的保留时间为1.95min，FEN的保留时间为5.50min。校准曲线在ATO和FEN浓度范围为3 - 15μg/mL时呈线性（ATO的r = 0.9985，FEN的r = 0.9976）。两种方法均经过验证，并对结果进行了统计学比较。发现它们准确、精密且具有特异性。这些方法已成功应用于复方片剂制剂中ATO和FEN的测定。
