Development and Validation of RP-HPLC Method for the Determination of Dexrabeprazole Sodium

Year 2021, Volume: 25 Issue: 6, 1427 - 1431, 31.12.2021

Semra Yılmazer Keskin Ebru Nurdan Şentürk Cihansel Unlu

https://doi.org/10.16984/saufenbilder.999458

Abstract

A rapid and simple liquid chromatographic method was developed for the quantitative determination of dexrabeprazole sodium in the tablet dosage form. The reverse-phase chromatographic analysis was carried out by using a C-18 column. The acetonitrile-phosphate buffer mixture was used as the mobile phase. The obtained retention time was 4.33∓0.02 min. by using 50:50 (v:v) acetonitrile:phosphate buffer(pH 7) and 1.0 mL/min. flow rate. Quantification of the analyte was based on measuring the peaks areas at 272 nm. The analytical performance of the developed RP-HPLC method was validated with respect to accuracy, precision, linearity, stability, and robustness. The obtained linearity range was 77-143 mg/L and the correlation coefficient was 0.9989. The obtained LOD and LOQ values were 0.010 mg/L and 0.034 mg/L, respectively.

Keywords

Dexrabeprazole, RP-HPLC, validation

References

• [1] X. M. Xia, H. Wang, "Gastroesophageal reflux disease relief in patients treated with rabeprazole 20 mg versus omeprazole 20 mg: a meta-analysis, Gastroenterol. Res. Pract. 2013.
• [2] S. S. Chitlange, A. I.Mulla, G. R. Pawbake, S. B. Wankhede, "Simultaneous spectrophotometric estimation of telmisartan and ındapamide in capsule dosage form," Int. J. Pharm. Qual. Assur., vol. 2, no. 2, pp. 31–34, 2010.
• [3] M. Gülfen, Y. Canbaz, A. Özdemir, "Simultaneous determination of amoxicillin, lansoprazole, and levofloxacin in pharmaceuticals by HPLC with UV–Vis detector," J. Anal. Test. vol. 4, no. 1, pp. 45-53, 2020.
• [4] M. Kim, S. K. Yu, Q. K. Truong, X. L. Mai, H. K. Chung, J. S. Kang, K. H. Kim, "Determination of rabeprazole enantiomers in commercial tablets using ımmobilized cellulose-based stationary phase," Arch. Pharm. Res., vol. 40, no. 3, pp. 373-381, 2017.
• [5] M. Miura, H. Tada, S. Satoh, T. Habuchi, T. Suzuki, "Determination of rabeprazole enantiomers and their metabolites by high-performance liquid chromatography with solid-phase extraction," J. Pharm. Biomed. Anal. vol. 41, no. 2, pp. 565-570, 2006.
• [6] C. Su, H. Yang, X. Meng, J. P. Fawcett, J. Cao, Y. Yang, J. Gu, "Determination of Rabeprazole enantiomers in dog plasma by supercritical fluid chromatography tandem mass spectrometry and ıts application to a pharmacokinetic study," J. Sep. Sci., vol. 40, no. 4, pp. 1010-1016, 2017.
• [7] P. S. Shedpure, P. A. Patel, S. D. Sawant, M. N. Dole, "Spectrophotometeric determination of dexrabeprazole sodium and domperidone maleate in bulk and capsule dosage form by first order derivative spectroscopy," Res. J. Pharm. Technol., vol. 4, no. 7, pp. 10886-1089, 2011.
• [8] S. T. Khadangale, V. M. Dhalape, R. V. Pinjari, "Development and validation of rapid, sensitive RP-UPLC method for determination of related ımpurities in dexrabeprazole sodium," Orient. J. Chem. vol. 34, no. 5, pp. 2425-2434, 2018.
• [9] S. S. Chitlange, A. I. Mulla, G. R. Pawbake, S. B. A. Wankhede, "A validated RP-HPLC method for simultaneous estimation of dexrabeprazole and domperidone in pharmaceutical dosage form," Der Pharm. Sin., vol. 1, no. 1, pp. 42-47, 2010.
• [10] E. M. European Medicines Agency: An Unacceptable Choice Prescrire Int. vol. 20, no. 121, pp. 278, 2011.