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一种用于测定奥美拉唑多潘立酮胶囊中杂质的单梯度稳定性指示反相液相色谱法

A Single Gradient Stability-Indicating Reversed-Phase LC Method for the Estimation of Impurities in Omeprazole and Domperidone Capsules.

作者信息

Seshadri Raja Kumar, Raghavaraju Thummala Veera, Chakravarthy Ivon Elisha

机构信息

Analytical Research and Development, Integrated Product Development, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad-500 072, India.

出版信息

Sci Pharm. 2013 Apr-Jun;81(2):437-8. doi: 10.3797/scipharm.1209-12. Epub 2012 Nov 19.

DOI:10.3797/scipharm.1209-12
PMID:23833712
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3700074/
Abstract

A gradient reversed-phase liquid chromatographic (RP-LC) method was developed for the quantitative estimation of impurities in the pharmaceutical dosage form of Omeprazole and Domperidone capsules. The developed method is a stability-indicating test method for the estimation of impurities generated during the formulation and storage of Omeprazole and Domperidone capsules. The chromatographic separation was achieved on a column packed with octadecyl silane, having a column length of 250 mm and diameter of 4.6 mm with a particle size of 5 μm, and by following a gradient program using a combination of a monobasic potassium phosphate buffer (0.05M) and acetonitrile. Since the spectral properties were similar, both compounds' individual impurities were estimated at 285 nm. Forced degradation studies were performed on Omeprazole pellets (enteric coated) and Domperidone pellets (SR coated) encapsulated in size '1' hard gelatin capsules. Omeprazole and Domperidone were degraded using acid hydrolysis (0.1 N hydrochloric acid), base (0.1 N sodium hydroxide), oxidation (50% hydrogen peroxide), heat (105 °C), and UV light (254 nm). The established method was validated and found to be linear, accurate, precise, specific, robust, and rugged.

摘要

建立了一种梯度反相液相色谱（RP-LC）法，用于定量测定奥美拉唑多潘立酮胶囊剂中的杂质。所建立的方法是一种稳定性指示试验方法，用于测定奥美拉唑多潘立酮胶囊在制剂过程和储存期间产生的杂质。采用填充十八烷基硅烷的色谱柱进行色谱分离，柱长250mm，内径4.6mm，粒径5μm，并采用磷酸二氢钾缓冲液（0.05M）和乙腈组合的梯度洗脱程序。由于两种化合物的光谱性质相似，其各自的杂质均在285nm处进行测定。对装入1号硬明胶胶囊中的奥美拉唑微丸（肠溶包衣）和多潘立酮微丸（缓释包衣）进行了强制降解研究。采用酸水解（0.1N盐酸）、碱（0.1N氢氧化钠）、氧化（50%过氧化氢）、加热（105℃）和紫外线（254nm）对奥美拉唑和多潘立酮进行降解。所建立的方法经过验证，结果表明具有线性、准确性、精密度、特异性、稳健性和耐用性。

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