Dubey Ramkumar, Bhusari Vidhya K, Dhaneshwar Sunil R
Department of Pharmaceutical Chemistry, Bharati Vidyapeeth University, Poona College of Pharmacy, Pune, Maharashtra, 411038, India.
Sci Pharm. 2011 Jul-Sep;79(3):545-54. doi: 10.3797/scipharm.1105-13. Epub 2011 Jun 26.
A HPLC method has been described for simultaneous determination of Losartan potassium and Metolazone in formulation. This method is based on a HPLC separation of the two drugs on the Thermo Hypersil BDS-C(18) (250 mm × 4.6 mm, 5.0 μm) with isocratic conditions and a simple mobile phase containing acetonitrile:water (60:40) at a flow rate of 0.8 mL/min using UV detection at 237 nm. This method has been applied to a marketed formulation without interference of excipients. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 2-12 μg/mL for Losartan potassium and 0.2-1.2 μg/mL for Metolazone, respectively. The method was validated for precision, robustness and recovery. Statistical analysis showed that the method is repeatable and selective for the estimation of Losartan potassium and Metolazone.
已描述了一种用于同时测定制剂中氯沙坦钾和美托拉宗的高效液相色谱法。该方法基于在Thermo Hypersil BDS-C(18)(250 mm×4.6 mm,5.0μm)上对两种药物进行高效液相色谱分离,采用等度条件,流动相为简单的乙腈:水(60:40),流速为0.8 mL/min,在237 nm处进行紫外检测。该方法已应用于市售制剂,未受到辅料的干扰。校准曲线的线性回归分析数据表明,氯沙坦钾在2 - 12μg/mL浓度范围内,美托拉宗在0.2 - 1.2μg/mL浓度范围内分别呈现良好的线性关系。该方法在精密度、稳健性和回收率方面得到了验证。统计分析表明,该方法对于氯沙坦钾和美托拉宗的测定具有可重复性和选择性。