International Journal of Applied Science and Engineering
Published by Chaoyang University of Technology

Dilip G Maheshwari a and Priti D Trivedi b,[1]

a L J Institute of Pharmacy, Near Nagdev Kalyan Mandir, Sanand Cross Roads, Ahmedabad, Gujarat, India.
b K. B. Institute of Pharmaceutical Education and Research, Sector-23, GH-6, Gandhinagar, Gujarat, India.


 

Download Citation: |
Download PDF


ABSTRACT


A simple, accurate, reliable and reproducible HPLC method was developed for the simultaneous determination of esomeprazole and domperidone in combined dosage forms. The method employed C18 phenomenex column, acetate buffer: acetonitrile: methanol (55:35:10) as mobile phase and detection was made at 290nm. The retention times were found to be 6.76 and 4.42 min for ESO and DOMPE respectively. The method was validated as per ICH guidelines. The method shows good linearity, accuracy, and precision, limit of detection and limit of quantification. The linearity range was found between 4-19 µg/mL for both ESO and DOMPE with relative standard deviation of 0.022 and 0.076 respectively. The value for LOD was found to be 0.3 µg/mL and 0.4 µg/mL and LOQ was found to be 1.5 µg/mL and 2.5 µg/mL for ESO and DOMPE respectively. The main recovery was found to be 99.81 ± 1.27 and 100.43 ± 1.15 for ESO and DOMPE respectively. The method was suitable for routine analysis of ESO and DOMPE both individually and in combined dosage forms.


Keywords: Simultaneous determination; HPLC; Esomeprazole; Domperidone


Share this article with your colleagues

 


REFERENCES


  1. [1] Andersson, T., Hassan-Alin, M., Hasselgren, G., Rohss., and K., Weidolf, L. 2001. Pharmacokinetic studies with esomeprazole, the (S)-Isomer of omeprazole. Clinical Pharmacokinetics, 40: 411-26.

  2. [2] Scott, L. J., Dunn, C. J., Mallarkey, G., and Sharpe, M. 2002.  Esomeprazole-A review of its use in the management of acid-related disorders. Drugs, 62: 1503-38.

  3. [3] Press, Merck & Co., Inc. Budavari, S. 2001. “The Merck Index”, 13th Ed., Whitehouse Station, NJ, 3476.

  4. [4] Castro, D., Moreno, M. A., Torrado, S., and Lastres, J. L. 1999. Comparison of derivative spectrophotometric and liquid chromatographic methods for the determination of omeprazole in aqueous solution during stability studies. Journal of Pharmaceutical and Biomedical Analysis, 21: 291-08.

  5. [5] Ding, L., Yang, J., Yan, H. L., Zhang, Z. X., and An, D. K. 1999. Determination of omeprazole and its pharmacokinetics in human plasma by an improved HPLC method. Chinese Journal of Pharmaceutical Analysis, 17: 458-461.

  6. [6] Hassan-Alin, M., Andersson, T., Bredberg, E., and Rohss, K. 2000. Pharmacokinetics of esomeprazole after oral and intravenous administration of single and repeated doses to healthy subjects. European Journal of Clinical Pharmacology, 56- 1: 665-670.

  7. [7] Johnson, D. A., Roach, A. C., Carlsson, A. S., Karlsson, A. A., and Behr, D. E. 2003. Stability of esomeprazole capsule contents after in vitro suspension in common soft foods and beverages. Pharmacotherapy, 23: 731-4.

  8. [8] Li, X. Q., Anderson, T. B., Ahlstrom, M., and Weidolf, L. 2004. Comparison of inhibitory effects of the proton pump-inhibiting drugs omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole on human cytochrome P450 activities. Drug Metabolism Dispos, 32: 821-7.

  9. [9] Nafisur, R., Zehra, B., and Syed, N. 2008. Spectrophotometric determination of esomeprazole magnesium in commercial tablets using 5-sulfosalicylic acid and N-bromosuccinimide. Journal of Chinese Chemistry Society, 55: 557-566.

  10. [10] Shetty, R., Subramanian, G., Ranjith Kumar, A., Pandey, S., and Udupa, N. 2005. Estimation of esomeprazole in human plasma by reverse phase high performance liquid chromatography. Indian Drugs, 42: 158-61.

  11. [11] Al-Khamis, K. L., Hagga, M. E., and Al–Khamis, H. A. 1990. Spectrophotometric determination of domperidone using absorbance difference method. Analytical Letters, 23: 451-60.

  12. [12] Ramamohan, Y., and Avadhanulu, A. B. 1998. Extractive spectrophotometric determination of domperidone in its pharmaceutical dosage forms. Indian Drugs, 35: 754-6.

  13. [13] Yamamoto, K., Hagino, M., Kotaki, H., and Iga I. 1998. Quantitative determination of domperidone in rat plasma by high performance liquid chromatography with fluorescence detection. Journal of Chromatography Biomedical Applied Science, 720: 252-5.

  14. [14] Argekar, A. P. and Shah, S. J. 1999. Simultaneous determination of cinnarizine and domperidone maleate from tablet dosage form by reverse phase ion pair high performance liquid chromatography. Journal of Pharmaceutical Biomedical Analysis, 19: 813-17.

  15. [15] Zarapkar, SS. and Kanyawar, NS. 2002. Simultaneous estimation of domperidone and omeprazole in pharmaceutical dosage by reverse phase high performance liquid chromatography. Indian Drugs, 39: 217-21.

  16. [16] Bhavesh, P., Madhabhai, P., Jignesh, P., and Bhanubhai, S. 2007. HPLC analysis for simultaneous determination of rabeprazole and domperidone in pharmaceutical formulation. Journal of Liquid Chromatography & Related Technologies, 30: 43-445.

  17. [17] Priti, T. and Dilip, M. 2010. Estimation of esomeprazole and domperidone by absorption ratio method in pharmaceutical dosage forms. International Journal of Chemtech Research, 2: 1598-1605.


ARTICLE INFORMATION




Accepted: 2011-07-06
Available Online: 2011-09-01


Cite this article:

Maheshwari, D.G., Trivedi, P.D. 2011. Simultaneous estimation of esomeprazole and domperidone in combined dosage form by HPLC. International Journal of Applied Science and Engineering, 9, 187–194. https://doi.org/10.6703/IJASE.2011.9(3).187


We use cookies on this website to improve your user experience. By using this site you agree to its use of cookies.