Barman Ranjan Kumar, Islam M Anwar Ul, Ahmed Maruf, Ibne Wahed Mir Imam, Islam Robiul, Khan Alam, Hossain M Belal, Rahman Bytul M
Quality Compliance Department, Square Pharmaceuticals Ltd., Pabna-6600, Bangladesh.
Pak J Pharm Sci. 2007 Oct;20(4):274-9.
A simple, rapid and precise method is developed for the quantitative simultaneous determination of atenolol and amlodipine in a combined pharmaceutical-dosage form. The method is based on High Performance Liquid Chromatography (HPLC) on a reversed-phase column, shim-pack CLC, ODS (C18), 4.6 mmx25 cm & 0.5 mm, using a mobile phase of ammonium acetate buffer (the pH was adjusted to 4.5+/-0.05 with glacial acetic acid), acetonitrile and methanol (35::30:35 v/v). The buffer used in the mobile phase contains ammonium acetate in double-distilled water. The chromatographic conditions are- flow rate of 1.5 ml/min, column temperature at 40 degrees C and detector wavelength of 237 nm. Both the drugs were well resolved on the stationary phase and the retention times were around 1.5 minute for atenolol and 3.4 minute for amlodipine. The method was validated and shown to be linear for atenolol and amlodipine. The correlation coefficients for atenolol and amlodipine are 0.999963 and 0.999979, respectively. The relative standard deviations for six replicate measurements in two sets of each drug in the tablets is always less than 2% and mean % error of active recovery not more than +/-1.5%. The method was validated for precision and accuracy. The proposed method was successfully applied to the pharmaceutical dosage forms containing the above-mentioned drug combination without any interference by the excipients.
开发了一种简单、快速且精确的方法，用于同时定量测定复方药物剂型中的阿替洛尔和氨氯地平。该方法基于反相柱Shim-pack CLC ODS（C18）（4.6 mm×25 cm，0.5 mm）上的高效液相色谱法（HPLC），流动相为醋酸铵缓冲液（用冰醋酸将pH值调至4.5±0.05）、乙腈和甲醇（35::30:35 v/v）。流动相中使用的缓冲液在双蒸水中含有醋酸铵。色谱条件为：流速1.5 ml/min，柱温40℃，检测波长237 nm。两种药物在固定相上均得到良好分离，阿替洛尔的保留时间约为1.5分钟，氨氯地平的保留时间约为3.4分钟。该方法经过验证，对阿替洛尔和氨氯地平呈线性。阿替洛尔和氨氯地平的相关系数分别为0.999963和0.999979。片剂中每种药物两组六次重复测量的相对标准偏差始终小于2%，活性回收率的平均百分误差不超过±1.5%。该方法的精密度和准确度经过验证。所提出的方法成功应用于含有上述药物组合的药物剂型，不受辅料干扰。
