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首页> 外文期刊>International Journal of Pharmaceutical Sciences and Research >DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IVABRADINE AND METOPROLOL IN TABLET DOSAGE FORM
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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IVABRADINE AND METOPROLOL IN TABLET DOSAGE FORM

机译:稳定性表明RP-HPLC方法及其在片剂剂型中同时估计Ivabradine和氟托洛尔的稳定性

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摘要

The objective of the method is to develop a rapid, simple, accurate, precise RP-HPLC method for the simultaneous estimation of Ivabradine and Metoprolol in tablet dosage form. The analytes were run through BDS C 18 150 × 46 mm, 5μm column, and detected at a wavelength of 260 nm using PDA 996 (photodiode array) detector. Mobile phase containing buffer 0.01N disodium hydrogen phosphate (3.5±1 pH) and acetonitrile in the ratio of 65:35 v/v was pumped through the column at a flow rate of 1.0ml/min and run time is about 6 min. The temperature was maintained at 30 °C. Retention times of ivabradine and metoprolol were found to be 2.38 min and 3.53 min. Percentage RSD of ivabradine and metoprolol was found to be 0.4 and 0.7, respectively. Percentage recovery of ivabradine and metoprolol were found to be 99.80% and 100.11%. LOD and LOQ values obtained from regression equations of ivabradine and metoprolol were found to be 0.03, 0.08, and 0.26, 0.79, respectively. The degradation studies were performed by applying different stress conditions like acidic, basic, thermal, photolytic, and results revealed that the method was a stable method. The developed method has good sensitivity, reproducibility, and specificity for the determination of ivabradine and metoprolol in bulk and its dosage form. The degradation studies were found to be stable and have the ability to separate degradation products in pharmaceutical dosage form and can be successfully applied for the simultaneous estimation of ivabradine and metoprolol in commercially available tablet dosage forms.
机译:该方法的目的是开发一种快速,简单,准确,精确,精确的RP-HPLC方法,用于同时估计片剂剂型中的Ivabradine和氟洛尔醇。分析物通过BDS C 18 150×46mm,5μm柱进行,并且使用PDA 996(光电二极管阵列)检测器在260nm的波长下检测。含有缓冲液0.01N磷酸二钠(3.5±1 pH)和乙腈的流动相以1.0ml / min的流速泵送65:35V / V的比例,并运行时间约为6分钟。将温度保持在30℃。发现Ivabradine和美容托洛尔的保留时间为2.38分钟和3.53分钟。发现Ivabradine和富含托洛尔的百分比分别为0.4和0.7。发现Ivabradine和富含托洛尔的百分比恢复为99.80%和100.11%。发现从Ivabradine和氟洛尔洛尔的回归方程获得的LOD和LOQ值分别为0.03,0.08和0.26,0.79。通过施加不同的应激条件,如酸性,碱性,热,光解,结果施加不同的应激条件,表明该方法是稳定的方法。开发方法具有良好的敏感性,再现性和特异性,用于测定散装和其剂型中的Ivabradine和甲状腺罗酚。发现降解研究是稳定的并且能够分离药物剂型中的降解产物,并且可以成功地应用于市售的片剂剂型中的Ivabradine和氟洛尔洛酚的同时估计。

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