Panchal Hiral J, Suhagia Bhanubhai N
Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat Vidyanagar, Kherva, Mehsana-382711, Gujarat, India.
J AOAC Int. 2010 Sep-Oct;93(5):1450-7.
Two simple and accurate methods to determine atorvastatin calcium and ramipril in capsule dosage forms were developed and validated using HPLC and HPTLC. The HPLC separation was achieved on a Phenomenex Luna C18 column (250 x 4.6 mm id, 5 microm) in the isocratic mode using 0.1% phosphoric acid-acetonitrile (38 + 62, v/v), pH 3.5 +/- 0.05, mobile phase at a flow rate of 1 ml/min. The retention times were 6.42 and 2.86 min for atorvastatin calcium and ramipril, respectively. Quantification was achieved with a photodiode array detector set at 210 nm over the concentration range of 0.5-5 microg/mL for each, with mean recoveries (at three concentration levels) of 100.06 +/- 0.49% and 99.95 +/- 0.63% RSD for atorvastatin calcium and ramipril, respectively. The HPTLC separation was achieved on silica gel 60 F254 HPTLC plates using methanol-benzene-glacial acetic acid (19.6 + 80.0 + 0.4, v/v/v) as the mobile phase. The Rf values were 0.40 and 0.20 for atorvastatin calcium and ramipril, respectively. Quantification was achieved with UV densitometry at 210 nm over the concentration range of 50-500 ng/spot for each, with mean recoveries (at three concentration levels) of 99.98 +/- 0.75% and 99.87 +/- 0.83% RSD for atorvastatin calcium and ramipril, respectively. Both methods were validated according to International Conference on Harmonization guidelines and found to be simple, specific, accurate, precise, and robust. The mean assay percentages for atorvastatin calcium and ramipril were 99.90 and 99.55% for HPLC and 99.91 and 99.47% for HPTLC, respectively. The methods were successfully applied for the determination of atorvastatin calcium and ramipril in capsule dosage forms without any interference from common excipients.
采用高效液相色谱法（HPLC）和高效薄层色谱法（HPTLC）开发并验证了两种简单且准确的测定胶囊剂型中阿托伐他汀钙和雷米普利的方法。HPLC分离在Phenomenex Luna C18柱（250×4.6 mm内径，5μm）上以等度洗脱模式进行，流动相为0.1%磷酸-乙腈（38 + 62，v/v），pH 3.5±0.05，流速为1 ml/min。阿托伐他汀钙和雷米普利的保留时间分别为6.42和2.86分钟。使用光电二极管阵列检测器在210 nm波长下对每种药物在0.5 - 5μg/mL的浓度范围内进行定量，阿托伐他汀钙和雷米普利的平均回收率（在三个浓度水平）分别为100.06±0.49%和99.95±0.63%（RSD）。HPTLC分离在硅胶60 F254 HPTLC板上进行，流动相为甲醇-苯-冰醋酸（19.6 + 80.0 + 0.4，v/v/v）。阿托伐他汀钙和雷米普利的Rf值分别为0.40和0.20。使用紫外光密度计在210 nm波长下对每种药物在50 - 500 ng/斑点的浓度范围内进行定量，阿托伐他汀钙和雷米普利的平均回收率（在三个浓度水平）分别为99.98±0.75%和99.87±0.83%（RSD）。两种方法均根据国际协调会议指南进行了验证，结果表明它们简单、特异、准确、精密且稳健。HPLC法测定阿托伐他汀钙和雷米普利的平均含量百分比分别为99.90%和99.55%，HPTLC法分别为99.91%和99.47%。这些方法成功应用于胶囊剂型中阿托伐他汀钙和雷米普利的测定，不受常见辅料的干扰。
