Talluri M V N Kumar, Kalyankar Anitha, Ragampeta Srinivas
Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education & Research, Balanagar, Hyderabad 500 037, India.
NCMS, Indian Institute of Chemical Technology, Tarnaka, Hyderabad 500 007, India.
J Pharm Anal. 2012 Aug;2(4):285-292. doi: 10.1016/j.jpha.2012.02.006. Epub 2012 Mar 13.
A new rapid and sensitive high performance liquid chromatography (HPLC) method has been developed for the simultaneous determination of atorvastatin-an antihyperlipidemic drug along with most commonly prescribed drugs (antihyperlipidemic, antihypertensive, antidiabetic, antithrombotic) in bulk and marketed combined formulations. The chromatographic separation was carried out by gradient elution mode with acetonitrile as organic modifier and 0.1% triethylamine acetate (TEAA) buffer pH 5 at a flow rate of 1 mL/min and a diode array detector at wavelength 230 nm was employed for detection of the analytes. Calibration curves were linear in the range of 5-150 μg/mL for all the drugs with correlation coefficients of determination ( values)≥0.999. Limits of detection (LODs) and Limits of quantification (LOQs) ranged from 0.1 to 0.27 μg/mL and 0.3 to 0.89 μg/mL respectively. Intra-day and inter-day precision was studied at three concentration levels (20, 60 and 100 μg/mL). The intra-day and inter-day RSD for all compounds was less than 2.0%. The accuracy for all compounds was found to be between 98% and 102%. Thus, the performance of the method described allows its use in quantification of atorvastatin along with 9 most commonly prescribed drugs available in market as atorvastatin combined dosage forms.
已开发出一种新型快速灵敏的高效液相色谱（HPLC）方法，用于同时测定抗高血脂药物阿托伐他汀以及散装和市售复方制剂中最常用的处方药（抗高血脂药、抗高血压药、抗糖尿病药、抗血栓药）。色谱分离采用梯度洗脱模式，以乙腈作为有机改性剂，0.1%三乙胺乙酸盐（TEAA）缓冲液（pH 5），流速为1 mL/min，并使用波长为230 nm的二极管阵列检测器检测分析物。所有药物的校准曲线在5 - 150 μg/mL范围内呈线性，测定系数（ 值）≥0.999。检测限（LOD）和定量限（LOQ）分别为0.1至0.27 μg/mL和0.3至0.89 μg/mL。在三个浓度水平（20、60和100 μg/mL）下研究了日内和日间精密度。所有化合物的日内和日间相对标准偏差（RSD）均小于2.0%。发现所有化合物的准确度在98%至102%之间。因此，所述方法的性能使其可用于定量分析阿托伐他汀以及市场上作为阿托伐他汀复方剂型的9种最常用处方药。
