A normal-phase high-performance thin-layer chromatographic (HPTLC) method has been established for quantitative estimation of itopride hydrochloride, a gastroprokinetic agent, in its pharmaceutical formulation and in the bulk drug substance. Analysis was performed on silica gel 60F
TLC plates with methanol-ethyl acetate-toluene-triethylamine, 1.0 + 2.5 + 6.0 + 0.5 (
), as mobile phase. Detection and quantitation were performed densitometrically at 1 = 230 nm. Diltiazem hydrochloride was used as the internal standard. Response to itopride hydrochloride was found to be linear in the concentration range 50.00 to 2000.00 μg mL
. The method was validated for accuracy and precision. Accuracy was checked by conducting recovery studies; the average recovery was found to be 99.27%. The method is simple, rapid, and precise and can be used for routine quality control.
T. Tsubouchi, T. Saito, F. Mizutani, T. Yamauchi, and Y. Wanaga
, J. Pharmacol. Exp. Ther.
Wanaga Y. , '' (2003) 306J. Pharmacol. Exp. Ther.: 787-793.
Wanaga Y. J. Pharmacol. Exp. Ther.2003306787793)| false
T. Mushiroda, R. Douya, E. Takahara, and O. Nagata
, Drug Metab. Disp.
Nagata O. , '' (2000) 28Drug Metab. Disp.: 1231-1237.
Nagata O. Drug Metab. Disp.20002812311237)| false
N. Mealy and J. Castaner
, Drug Future
Castaner J. , '' (1995) 20Drug Future: 1220-1223.
Castaner J. Drug Future19952012201223)| false
S.S. Singh, M. Jain, K. Sharma, B. Shah, and M. Vyas
, J. Chromatogr. B
Vyas M. , '' (2005) 818J. Chromatogr. B: 213-220.
Vyas M. J. Chromatogr. B2005818213220)| false
E. Takahara and H. Fukuoka
, J. Chromatogr.
Fukuoka H. , '' (1992) 576J. Chromatogr.: 174-178.
Fukuoka H. J. Chromatogr.1992576174178)| false
N. Kaul, H. Agrawal, P. Maske, J.R. Rao, K. Mahadik, and S. Kadam
, J. Sep. Sci.
Kadam S. , '' (2005) 28J. Sep. Sci.: 1566-1576.
Kadam S. J. Sep. Sci.20052815661576)| false
ICH Guidance on Analytical Method Validation. In: Proceedings of the International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September 2002.
, High Performance Thin Layer Chromatography, Quantitative Analysis of Pharmaceutical Formulations, CBS Publishers and Distributors, New Delhi, 1996.
Sethi P.D. , '', in High Performance Thin Layer Chromatography, Quantitative Analysis of Pharmaceutical Formulations, (1996) -.
Sethi P.D. High Performance Thin Layer Chromatography, Quantitative Analysis of Pharmaceutical Formulations1996)| false