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首页> 外文期刊>Pharmaceutical Methods >Analytical Validation and Stability Indicating Studies for Simultaneous Estimation of Benidepine and Metoprolol by Strong Cation Exchange (SCX) Chromatography
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Analytical Validation and Stability Indicating Studies for Simultaneous Estimation of Benidepine and Metoprolol by Strong Cation Exchange (SCX) Chromatography

机译：通过强阳离子交换（SCX）色谱法同时估计Benidepine和氟洛尔酚的分析验证和稳定性

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Introduction: Polar anti-hypertensive drugs like benidepine and metoprolol often suffer from peak fronting and peak tailing effects in RP-HPLC. SCX chromatography which is alternative and complimentary to this RP-HPLC also has the capability to separate benidepine and metoprolol. Considering these aspects, SCX method was developed with performing stability indicating studies for the simultaneous quantification of benidepine (BEN) and metoprolol (MET) in bulk and tablet formulation. Methods: This investigation was performed on the Phenomenex Luna SCX column (100 × 2.1 mm, ID, particle size 5 μm) where both BEN and MET were eluted with ammonium formate (15mM) buffer: MeOH in ratio of 75:25 v/v for 12 min with isocratic elution at the flow rate of 1.2 ml/min; performed at 28°C and monitored at 226 nm wavelength. Results: The average retention time of BEN and MET were 1.290 and 3.520 min, respectively. The validation studies revealed good linearity over different concentration ranging between 7.5-250 μg/ml for BEN and 15.5-250 μg/ml for MET with Rsup2/sup values were 0.999 recorded for both drugs. Average drug recoveries of BEN and MET were ranging between 99.36±0.83% and 100.51±1.03%, respectively. The acid (0.1N HCl; 50°C), dry heat (50°C) and alkali (0.1N NaOH; 50°C) have not made any significant changes in both BEN and MET but peroxide (3% Hsub2/subOsub2/sub; 28°C) have degraded the BEN but MET was unaffected. Conclusion: The present SCX method represented the shortest run time for the investigation of benidipine and metoprolol where the results of linearity, accuracy, precision, robustness and specificity were under the obligation of ICH guidelines.
机译：简介：诸如Banidepine和MetoColol等极性抗高血压药物通常在RP-HPLC中遭受峰值前部和峰尾效应。 SCX色谱法替代和互补于该RP-HPLC的能力也具有分离的Banidepine和氟托洛尔。考虑到这些方面，SCX方法是通过进行批量和片剂配方中同时定量Banidepine（Ben）和氟托洛尔（Met）的稳定性表明研究的稳定性。方法：本研究对现象呼吸SCX柱（100×2.1mm，ID，粒径5μm）进行，其中BEN和MET均用甲酸铵（15mm）缓冲液洗脱：MeOH以75:25 V / V的比例进行在1.2ml / min的流速下等12分钟;在28°C下进行并在226nm波长下监测。结果：本率的平均保留时间分别为1.290和3.520分钟。验证研究揭示了在本率为7.5-250μg/ ml的不同浓度范围内的良好线性，并且对于r 2℃的r 2的值为0.999，为两种药物均为0.999。本Ben和达到的平均药物回收率分别在99.36±0.83％和100.51±1.03％之间。酸（0.1N HCl; 50℃），干热（50℃）和碱（0.1N NaOH; 50℃）没有在本Ben中的任何显着变化并满足过氧化物（3％H 2 O 2 ; 28°C）降解了本Ben，但遇见不受影响。结论：本发明的SCX方法代表了苯特异线和​​美托洛尔调查的最短运行时间，其中线性度，准确性，精确度，鲁棒性和特异性的结果是ICH指南的义务。

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