Chromatographic determination of itopride hydrochloride in the presence of its degradation products

Abstract

Two sensitive and reproducible methods are described for the quantitative determination of itopride hydrochloride (IH) in the presence of its degradation products. The first method is based on HPLC separation on a reversed phase Kromasil column [C18 (5-microm, 25 cm x 4.6 mm, ID)] at ambient temperature using a mobile phase consisting of methanol and water (70:30, v/v) adjusted to pH 4.0 with orthophosphoric acid with UV detection at 258 nm. The flow rate was 1.0 mL per min with an average operating pressure of 180 kg/cm2. The second method is based on HPTLC separation on silica gel 60 F254 using toluene:methanol:chloroform:10% ammonia (5.0:3.0:6.0:0.1, v/v/v/v) as mobile phase at 270 nm. The analysis of variance (ANOVA) and Student's t-test were applied to correlate the results of IH determination in dosage form by means of HPLC and HPTLC methods. The drug was subjected to acid and alkali hydrolysis, oxidation, dry heat, wet heat treatment, UV, and photodegradation. The proposed HPLC method was utilized to investigate the kinetics of the acidic, alkaline, and oxidative degradation processes at different temperatures and the apparent pseudo-first-order rate constant, half-life, and activation energy were calculated. In addition the pH-rate profile of degradation of IH in constant ionic strength buffer solutions in the pH range 2-11 was studied.

Simultaneous determination of a binary mixture of pantoprazole sodium and itopride hydrochloride by four spectrophotometric methods

“…Several analytical methods have been developed for the determination of PAN in pharmaceutical preparations such as spectrophotometric methods [3][4][5][6], HPLC methods [7][8][9][10], HPTLC-densitometric methods [11,12] and liquid chromatographic-tandem mass methods (LC-MS/MS) [13,14]. Also several methods have been reported for the determination of ITH in pharmaceutical preparations such as spectrophotometric methods [15][16][17], HPLC methods [18][19][20], HPTLC-densitometric methods [21,22] and spectroflourimetric methods [23]. Simultaneous determination of PAN and ITH has been achieved by different spectrophotometric methods [24][25][26], HPLC methods [27,28], HPTLCdensitometric methods [29], spectroflourimetric methods [23].…”

A study of selective spectrophotometric methods for simultaneous determination of Itopride hydrochloride and Rabeprazole sodium binary mixture: Resolving sever overlapping spectra

“…Quite a lot of analytical methods were reported for the determination of Itopride hydrochloride in its pure form, pharmaceutical preparations and human plasma, including spectrophotometric methods [3][4][5], electrochemical method [6], TLC [7], liquid chromatography with ultraviolet detection [8][9][10][11][12], chemiluminescence detection [13] and fluorescence detection [14][15][16]. On the other hand, RB was analyzed by applying several methods like; spectrophotometric methods [17][18][19][20][21][22], chemometric method [23] and spectroflourimetric methods [24,25].…”

Fourth‐derivative synchronous spectrofluorimetry and HPLC with fluorescence detection as two analytical techniques for the simultaneous determination of itopride and domperidone

“…The literature survey revealed that ITP has been determined by spectrophotometry , spectrofluorimetry , high‐performance thin‐layer chromatography (HPTLC) and several HPLC methods using UV , fluorescence , chemiluminescence and MS detection . Several methods have been reported for the determination of DOM including potentiometry , anodic differential pulse voltammetry , HPLC‐MS and HPLC with fluorescence detection .…”