A Novel Validated Rp-HPLC Method for the Determination of Itopride Hydrochloride in Bulk and Pharmaceutical Tablet Dosage Forms

Abstract

A simple, specific, accurate, rapid, inexpensive isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Itopride HCl in pharmaceutical tablet dosage forms. RP-HPLC method was developed by using Welchrom C18Column (4.6 X 250mm, 5µm), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of 10mM Phosphate buffer (pH-3.0, adjusted with triethylamine): acetonitrile (50:50v/v). The flow rate was set to 1.0 mL.min-1 with the responses measured at 235nm using Shimadzu SPD-20A Prominence UV-Vis detector. The retention time of Itopride HCl was found to be 2.650 min. Linearity was established for Itopride HCl in the range of 2-10 µg.mL-1 with correlation coefficient 0.9999. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be used for routine quality control analysis of Itopride HCl in pharmaceutical tablet dosage form.

Formulation and Characterization of Amisulpride Microemulsions for Brain Targeting via Intranasal Route-Pharmacodynamic Evaluation in Rat Model

“…Accurately weighed microemulsions were suitably diluted with methanol, sonicated, filtered through 0.45 µm filter and analysed by HPLC method. 29…”

Stability Indicating Rp-HPLC Method for Determination of Amisulpride in Tablet Dosage Form

“…Literature survey revealed different analytical methods for the estimation of Amisulpride in biological systems like HPLC using either UV or fluorescence detection and an IR, UV spectrophotometric and HPLC method are also reported. A UV spectrophotometric method, a chromatographic method and few electrophoretic methods are also reported for the quantitative estimation of Amisulpride in pharmaceutical formulations (Sachse et al 2003;Skibiński et al 2007;Ravisankar and Devala Rao, 2015a;2015b;Ascalone et al 1996). The stability-indicating assay is a method that is employed for the analysis of stability samples in pharmaceutical industry.…”

HPLC Assay Method Development and Validation for Quantification of Capecitabine in Tablets and Forced Degradation Samples

“…Another liquid chromatography-tandem mass spectrometry method for determination of capecitabine in dried blood spot, separation was done on Phenomenex Gemini C 18 column, isocratic condition for mobile phase as acetonitrile : 2 mmole ammonium formate (80:20, v/v) [16]. Reversed phase method was developed for capecitabine determination in bulk and pharmaceutical formulations where separation performed on Welchrom C 18 column with isocratic mobile phase containing methanol: acetonitrile: water (50:30:20, v/v) which was monitored at 245 nm, method was validated according to ICH guidelines [17]. Spectrophotometric methods were developed for determination of capecitabine based on their oxidation and precipitation reactions, which was monitored by measuring absorbance of produced complexes [18].…”