Perindopril erbumine is a specific inhibitor of angiotensin-converting enzyme, indapamide is the one providing thiazide diuretic effect, and amlodipine besylate is a calcium antagonist which belongs to the dihydropyridines which helps to maintain the pressure of the blood in the patient having arterial hypertension. The literature survey discloses that only one method is available for the estimation of the combination in the quantitative analytical liquid chromatographic method. Moreover to this, the literature review also reveals that HPTLC, UV spectroscopy, and HPLC methods are available for the analysis of either of the two in combination. Hence, our area of interest is to develop and validate the RP-HPLC in order to quantify perindopril erbumine, indapamide, and amlodipine besylate simultaneously in bulk and formulation. Sensitive and accurate RP-HPLC method was developed for the simultaneous estimation of indapamide, perindopril erbumine, and amlodipine besylate in bulk and available as triplixam-marketed tablet dosage form which is a combination of these drugs. The Phenomenex C-18 column (250 mm × 4.6 mm, 5 μm) was used as a stationary phase, and acetonitrile: methanol: water (30:20:50, v/v/v) was found to be optimized mobile phase which was further adjusted to pH 3.0 by utilizing 1.0% orthophosphoric acid; the flow rate kept was 1 ml/min and experiments were performed using PDA detector. The common detection wavelength for all the three APIs was found to be 215.0 nm. The method was validated as per ICH Q2 (R1). The linearity range for amlodipine besylate was found to be 0.500–9.500 μg/ml; for perindopril erbumine was found to be 0.400–7.600 μg/ml, and for indapamide was found to be 0.125–2.375 μg/ml. The correlation coefficient was found to be more than 0.9975 for all three of them, whereas the mean percentage recovery was found to be 99.52–100.71%, 99.49–100.89%, and 99.90–100.78%, respectively. The proposed RP-HPLC method is found to be accurate and robust enough to estimate the perindopril erbumine, indapamide, and amlodipine besylate simultaneously in bulk and available tablet dosage form of combination.

中文翻译：

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RP-HPLC的新方法，可同时定量散装和药物剂型中的培哚普利特丁胺，吲达帕酰胺和氨氯地平苯磺酸盐

Perindopril erbumine是一种特定的血管紧张素转化酶抑制剂，indapamide是一种提供噻嗪类利尿剂的抑制剂，amlodipine besylate是一种钙拮抗剂，属于二氢吡啶类，有助于维持患有高血压的患者的血液压力。文献调查显示，在定量分析液相色谱法中，只有一种方法可用于估算组合。除此之外，文献综述还显示，HPTLC，UV光谱法和HPLC方法可用于分析两者的组合。因此，我们感兴趣的领域是开发和验证RP-HPLC，以便同时定量地定量和定量测定培哚普利erbumine，indapamide和amlodipine besylate。建立了灵敏而准确的RP-HPLC方法，用于同时估算吲达帕胺，培哚普利特丁胺和苯磺酸氨氯地平的批量含量，并且可以作为三药的市售片剂剂型使用，这些剂型是这些药物的组合。使用Phenomenex C-18色谱柱（250 mm×4.6 mm，5μm）作为固定相，发现乙腈：甲醇：水（30:20:50，v / v / v）是最佳的流动相通过使用1.0％正磷酸将pH值进一步调节至3.0。保持的流速为1 ml / min，并使用PDA检测器进行实验。发现所有三种API的共同检测波长为215.0 nm。该方法已按照ICH Q2（R1）进行了验证。苯磺酸氨氯地平的线性范围为0.500–9.500μg/ ml；培哚普利特丁胺的含量为0.400–7.600μg/ ml，吲达帕胺的含量为0.125–2.375μg/ ml。他们三个人的相关系数均大于0.9975，而平均回收率分别为99.52-100.71％，99.49-100.89％和99.90-100.78％。已发现拟议的RP-HPLC方法准确，稳健，足以同时批量估计培哚普利特丁胺，吲达帕酰胺和苯磺酸氨氯地平和可用片剂剂型的组合。