DETERMINATION AND VALIDATION OF A HPLC METHOD WITH UV DETECTIONOF ITOPRIDE HYDROCHLORIDE IN HUMAN SERUM

Authors

  • Sreenivas Patro Sisinthy School of Pharmacy, Taylors University, Malaysia
  • Selvakumar Duraipandi Taylors University
  • Nalamolu Koteswara Rao Taylors University
  • Me Bhanoji Rao Roland Institute of Pharmaceutical Sciences, Berhampur

Keywords:

Itopride, Serum, Validation, UV-detection, Bioequivalence

Abstract

Objective: Determination and validation of a simple, sensitive and rapid reversed phase high-performance liquid chromatography method for the determination of itopride hydrochloride in human serum using nimesulide as an internal standard.

Methods: A liquid-liquid extraction method was employed to extract itopride hydrochloride from serum matrix with diethyl ether. Chromatographic separation was obtained within 10 min using a reverse phase C18 column (250 mm×4.6 mm, 5 µm) with an isocratic elution. The mobile phase consisting of a mixture acetonitrile and 0.05M phosphate buffer with a flow rate of 1.0 ml/min was used and the eluents were monitored at 258 nm.

Results: Calibration curves were linear (r2= 0.9987) in the range of 10ng/ml to 1000 ng/ml. The limit of quantitation was 14ng/ml. The mean recovery of itopride hydrochloride and the nimesulide from the biological matrix was more than 66.04 and 64.57%, respectively. The inter-day accuracy of the drug containing serum samples was more than 97.81% with a precision of 2.31–3.68%. The intra-day accuracy was 96.91% or more with a precision of 5.17–9.50%.

Conclusion: The developed method was validated and successfully applied to a bioequivalence study in healthy human volunteers.

 

Downloads

Download data is not yet available.

References

Kim YS, Kim TH, Choi CS, Shon YW, Kim S, Seo GS. Effect of itopride, a new prokinetic, in patients with mild GERD: a pilot study. World J Gastroenterol 2005;11:210–4.

Singh SS, Jain M, Sharma K, Shah B, Vyas M, Thakkar P, et al. Quantitation of itopride in human serum by high-performance liquid chromatography with fluorescence detection and its application to a bioequivalence study. J Chromatogr B 2005;818:213–20.

Ma J, Yuan LH, Ding MJ, Zhang J, Zhang Q, Xu, et al. Determination of itopride hydrochloride in human plasma by RP-HPLC with fluorescence detection and its use in bioequivalence study. Pharmacol Res 2009;59:189–93.

Ptaˇcek P, Klima J, Macek J. Optimized method for the determination of itopride in human plasma by high-performance liquid chromatography with fluorimetric detection. J Chromatogr B 2009;877:842–6.

Ibrahim F, Nasr JJ. Fourth-derivative synchronous spectrofluorimetry and HPLC with fluorescence detection as two analytical techniques for the simultaneous determination of itopride and domperidone. Luminescence 2015. doi: 10.1002/bio.2955. [Article in Press]

Lee HW, Seo JH, Choi SK, Lee KT. Determination of itopride in human plasma by liquid chromatography coupled to tandem mass spectrometric detection: application to a bioequivalence study. Anal Chim Acta 2007;583:118-23.

Zhou LP, Tan ZR, Chen H, Guo D, Chen Y, Huang WH, et al. Effect of two-linked mutations of the FMO3 gene on itopride metabolism in chinese healthy volunteers. Eur J Clin Pharmacol 2014;70:1333-8.

Bose A, Bhaumik U, Ghosh A, Chatterjee B, Chakrabarty US, Sarkar AK. LC–MS simultaneous determination of itopride hydrochloride and domperidone in human plasma. Chromatographia 2009;69:1233–41.

ICH Harmonized Tripartite Guidelines. Validation of analytical procedures: Text and Methodology, Q2-R1; 2005.

Garvey JS, Cremer NE, Sussdorf DH. Methods of Immunology: A Laboratory Text for Instruction and Research. 3rd ed. W A Benjamin Inc.; 1977.

Gibaldi M, Perrier D. Appendix C: Methods of Residuals. In: Pharmacokinetics, Marcel Dekker, New York; 1982.

Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. J Pharm Sci 1992;81:309-12.

Published

01-11-2015

How to Cite

Sisinthy, S. P., S. Duraipandi, N. K. Rao, and M. B. Rao. “DETERMINATION AND VALIDATION OF A HPLC METHOD WITH UV DETECTIONOF ITOPRIDE HYDROCHLORIDE IN HUMAN SERUM”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 11, Nov. 2015, pp. 246-9, https://innovareacademics.in/journals/index.php/ijpps/article/view/8326.

Issue

Section

Original Article(s)