苹果酸阿莫曲坦原料药及片剂的高效液相色谱分析
High performance liquid chromatographic analysis of almotriptan malate in bulk and tablets.
作者信息
Lavudu Petikam, Rani Avula Prameela, Divya Chepuri, Sekharan Chandra Bala
机构信息
Department of Pharmaceutical Biotechnology, Vishnu Institute of Pharmaceutical Education and Research, Narsapur, Andhra Pradesh-500072.
出版信息
Adv Pharm Bull. 2013;3(1):183-8. doi: 10.5681/apb.2013.030. Epub 2013 Feb 7.
PURPOSE
A simple RP-HPLC method has been developed and validated for the determination of almotriptan malate (ATM) in bulk and tablets.
METHODS
Chromatographic separation of ATM was achieved by using a Thermo Scientific C18 column. A Mobile phase containing a mixture of methanol, water and acetic acid (4:8:0.1 v/v) was pumped at the flow rate of 1 mL/min. Detection was performed at 227 nm. According to ICH guidelines, the method was validated.
RESULTS
The calibration curve was linear in the concentration range 5-60 µg/mL for the ATM with regression coefficient 0.9999. The method was precise with RSD <1.2%. Excellent recoveries of 99.60 - 100.80% proved the accuracy of the method. The limits of detection and quantification were found to be 0.025 and 0.075 µg/mL, respectively.
CONCLUSION
The method was successfully applied for the quantification of ATM in tablets with acceptable accuracy and precision.
目的
开发并验证了一种简单的反相高效液相色谱法（RP-HPLC），用于测定原料药和片剂中的苹果酸阿莫曲坦（ATM）。
方法
采用赛默飞世尔科技的C18色谱柱对ATM进行色谱分离。以甲醇、水和乙酸（4:8:0.1 v/v）的混合物为流动相，流速为1 mL/min。检测波长为227 nm。根据国际人用药品注册技术协调会（ICH）指南对该方法进行了验证。
结果
ATM在5-60 µg/mL浓度范围内校准曲线呈线性，回归系数为0.9999。该方法精密度良好，相对标准偏差（RSD）<1.2%。99.60 - 100.80%的出色回收率证明了该方法的准确性。检测限和定量限分别为0.025和0.075 µg/mL。
结论
该方法成功应用于片剂中ATM的定量分析，准确性和精密度均可接受。
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