采用胶束电动毛细管色谱法测定药物制剂中洛伐他汀和辛伐他汀的含量。
Determination of lovastatin and simvastatin in pharmaceutical dosage forms by MEKC.
作者信息
Srinivasu M K, Raju A Narasa, Reddy G Om
机构信息
Department of Analytical Research, Dr. Reddy's Research Foundation, Miyapur, 500050, Hyderabad, India.
出版信息
J Pharm Biomed Anal. 2002 Jul 20;29(4):715-21. doi: 10.1016/s0731-7085(02)00128-0.
A micellar electrokinetic chromatographic (MEKC) method was developed for the quantification of lovastatin and simvastatin, cholesterol lowering agents in pharmaceutical dosage forms. Lovastatin and simvastatin were separated using an electrolyte system consisting of 12% acetonitrile (v/v) in 25 mM sodium borate buffer pH 9.3 containing 25 mM sodium dodecyl sulphate (SDS) with an extended light path capillary (48.5 cm x 50 microm i.d, 40 cm to detector). The method has been validated and proven to be rugged. Calibration curves were linear over the studied ranges with correlation coefficients greater than 0.996. A limit of detection of 3.2 microg/ml and a limit of quantitation of 10.6 microg/ml were estimated for both the drugs. The proposed method was found to be suitable and accurate for the determination of these drugs in commercial formulations.
建立了一种胶束电动色谱（MEKC）方法，用于定量测定药物剂型中的降胆固醇药物洛伐他汀和辛伐他汀。使用由25 mM硼酸钠缓冲液（pH 9.3）中12%乙腈（v/v）组成的电解质系统分离洛伐他汀和辛伐他汀，该缓冲液含有25 mM十二烷基硫酸钠（SDS），采用延长光程毛细管（48.5 cm×50 μm内径，至检测器40 cm）。该方法已得到验证并证明具有耐用性。在所研究的范围内校准曲线呈线性，相关系数大于0.996。两种药物的检测限估计为3.2 μg/ml，定量限为10.6 μg/ml。结果表明，该方法适用于商业制剂中这些药物的测定，且准确可靠。
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