Abstract
An isocratic reversed phase high-performance liquid chromatographic method with ultraviolet detection at 220 nm has been developed for the quantification of itopride hydrochloride in tablet dosage form. The quantification was carried out using C8 column (250 mm × 4.6 mm), 5-μm particle size SS column. The mobile phase comprised of two solvents (Solvent A: buffer 1.4 mL ortho-phosphoric acid adjusted to pH 3.0 with triethyl amine and Solvent B: acetonitrile). The ratio of Solvent A: Solvent B was 75:25 v/v. The flow rate was 1.0 mL -1with UV detection at 220 nm. The method has been validated and proved to be robust. The calibration curve was linear in the concentration range of 80-120% with coefficient of correlation 0.9995. The percentage recovery for itopride HCl was 100.01%. The proposed method was validated for its selectivity, linearity, accuracy, and precision. The method was found to be suitable for the quality control of itopride HCl in tablet dosage formulation.
Highlights
Itopride hydrochloride (N-[4-[2-(dimethylamino)ethoxy] benzyl]-3,4-dimethoxybenzamide hydrochloride) is a novel gastroprokinetic agent, which stimulates gastrointestinal motor activity through synergistic effects of dopamine D2 receptor blockade and acetylcholine esterase inhibition.[1,2] Itopride HCl is prescribed for the gastrointestinal symptoms caused by reduced gastrointestinal mobility, e.g., a feeling of gastric fullness, upper abdominal pain, anorexia, heartburn, nausea and vomiting, caused by conditions such as functional dyspepsia or chronic gastritis
The extraction reported to detect itopride HCl was liquid-liquid extraction.[3,4,5]. This method presented some disadvantages such as being of low sensitivity, time consuming, and costly. They were reported for the determination of itopride HCl and its related substances in biological fluids like plasma, blood, and urine only but, not a single method has been reported for its determination in bulk and solid dosage forms by reversed phase high-performance liquid chromatographic (RP-HPLC) method
This study focused on the development of simple and rapid isocratic RPHPLC method which can be employed for the routine analysis of itopride HCl in bulk drug and formulations
Summary
Itopride hydrochloride (N-[4-[2-(dimethylamino)ethoxy] benzyl]-3,4-dimethoxybenzamide hydrochloride) is a novel gastroprokinetic agent, which stimulates gastrointestinal motor activity through synergistic effects of dopamine D2 receptor blockade and acetylcholine esterase inhibition.[1,2] Itopride HCl is prescribed for the gastrointestinal symptoms caused by reduced gastrointestinal mobility, e.g., a feeling of gastric fullness, upper abdominal pain, anorexia, heartburn, nausea and vomiting, caused by conditions such as functional dyspepsia or chronic gastritis. The extraction reported to detect itopride HCl was liquid-liquid extraction.[3,4,5] this method presented some disadvantages such as being of low sensitivity, time consuming, and costly. They were reported for the determination of itopride HCl and its related substances in biological fluids like plasma, blood, and urine only but, not a single method has been reported for its determination in bulk and solid (tablet) dosage forms by reversed phase high-performance liquid chromatographic (RP-HPLC) method. This study was designed to develop a simple and reliable method to quantitate itopride HCl in a relatively short time with high linearity. The established method was validated with respect to specificity, linearity, precision, accuracy, and ruggedness
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