Mondal Nita, Pal Tapan K, Ghosal Saroj K
Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, West Bengal, India.
Acta Pol Pharm. 2009 Jan-Feb;66(1):11-7.
This study describes development and subsequent validation of a reversed phase high performance liquid chromatographic (RP-HPLC) method for estimation of letrozole, a new aromatase inhibitor, in raw material, pharmaceutical formulations like tablets and nanoparticles and in release medium. The chromatographic system consisted of a FinePak C, column, an isocratic mobile phase composed of deionized water, acetonitrile and methanol (50:30:20 v/v/v) and UV detection at 240 nm. Letrozole was eluted at 9.8 min with no interfering peak of excipients used for the preparation of dosage forms. The method was linear over the range from 1 to 50 microg/mL in raw drug (R2 = 0.9999). The intra-day and inter-day precision values were in the range of 0.122-0.277%. Limit of detection and limit of quantitation were 0.207 microg/mL and 0.627 microg/mL, respectively. Results were validated statistically according to ICH guidelines in both tablets and nanoparticles. Validation of the method yielded good results concerning range, linearity, precision and accuracy. The method was successfully applied in drug release studies from nanoparticles. The release kinetics was found to be fitted into the Higuchi model.
本研究描述了一种反相高效液相色谱（RP-HPLC）方法的建立及后续验证，该方法用于测定原料药、片剂和纳米颗粒等药物制剂以及释放介质中新型芳香酶抑制剂来曲唑的含量。色谱系统由FinePak C柱、由去离子水、乙腈和甲醇（50:30:20 v/v/v）组成的等度流动相以及240 nm处的紫外检测组成。来曲唑在9.8分钟时洗脱，制备剂型所用辅料无干扰峰。该方法在原料药中1至50 μg/mL范围内呈线性（R2 = 0.9999）。日内和日间精密度值在0.122 - 0.277%范围内。检测限和定量限分别为0.207 μg/mL和0.627 μg/mL。根据ICH指南对片剂和纳米颗粒的结果进行了统计学验证。该方法在范围、线性、精密度和准确度方面验证结果良好。该方法成功应用于纳米颗粒的药物释放研究。发现释放动力学符合Higuchi模型。
