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

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.

The role of clarithromycin in modern <i>Helicobacter pylori</i> eradication therapy regimens

“…Для образования активных метаболитов, что требует последовательного протонирования в начале пиридинового, а затем бензимидазольного колец, оптимальным является постепенное снижение рН от среднекислых к сильнокислым значениям, что в просвете желудка маловероятно. Даже если в желудке образуются активные метаболиты, их свой ством является быстрое образование дисульфидных мостиков с остатками цистеина белков, ими обладаю щих, и такое связывание исключает продвижение по ЖКТ активированных ИПП и, соответственно, их абсорбцию [27][28][29]. Поэтому для обеспечения всасывания ИПП их лекарственные формы защищают кишечнорастворимыми полимерными оболочками.…”

Perspective Chapter: Multi-Dimensional Liquid Chromatography - Principles and Applications

“…The conditions developed in this 2D-LC approach can be considered more or less generic for detection of impurities in APIs, at least when eluting under reversed phase LC conditions. In this robust and method, good finds were also achieved for analyses of metoclopramide, acetaminophen, diclofenac, ibuprofen, and lidocaine [32][33][34][53][54][55][56].…”

Development and Validation of a Novel Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Related Substances of Ketoprofen and Omeprazole in Combined Capsule Dosage Form

“…An extensive literature survey found that a number of analytical methods have been reported in the literature for the individual determination of KET or OMZ. These methods include HPLC estimation (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20), UV spectrophotometry (21)(22)(23) and LC-MS estimation (24)(25)(26). The simultaneous assay determination of KET and OMZ in capsules was also reported (27).…”