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Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets

DOI: 10.1155/2013/976034

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Abstract:

The purpose of this study was to develop and validate a new reversed phase high performance liquid chromatographic (RP-HPLC) method to quantify in vitro dissolution assay of rabeprazole sodium in pharmaceutical tablet dosage form. Method development was performed on C 18, ?mm ID, and 10?μm particle size column, and injection volume was 20?μL using a diode array detector (DAD) to monitor the detection at 280?nm. The mobile phase consisted of buffer: acetonitrile at a ratio of 60?:?40 (v/v), and the flow rate was maintained at 1.0?mL/min. The method was validated in terms of suitability, linearity, specificity, accuracy, precision, stability, and sensitivity. Linearity was observed over the range of concentration 0.05–12.0?μg/mL, and the correlation coefficient was found excellent >0.999. The method was specific with respect to rabeprazole sodium, and the peak purity was found 99.99%. The method was precise and had relative standard deviations (RSD) less than 2%. Accuracy was found in the range of 99.9 to 101.9%. The method was robust in different variable conditions and reproducible. This proposed fast, reliable, cost-effective method can be used as quality control tool for the estimation of rabeprazole sodium in routine dissolution test analysis. 1. Introduction Since 1980s, proton pump inhibitors (PPIs) are the most potent inhibitors of gastric acid secretion and effective for treating all gastric acid-related disorders, including gastroesophageal reflux disease (GERD), peptic ulcer disease (PUD), and nonsteroidal anti-inflammatory drug- (NSAID-) induced gastropathy. Rabeprazole sodium (RPS) belongs to a class of PPIs that suppresses gastric acid secretion by specific inhibition of the enzyme system of hydrogen/potassium adenosine triphosphatase (H+/K+ ATPase) at the secretory surface of the gastric parietal cell. In contrast to the other PPIs, RPS is the most potent acid secretion inhibitor during first day of dosing [1]. RPS hinders gastric acid secretion up to the final steps [2]. It may also be used with an antibiotic to prevent gastric ulcer caused by infection Helicobacter pylori (H. pylori). Rabeprazole sodium is chemically 2-[{(4)3-methoxypropoxy-3-methyl-2-pyridinyl} sulphinyl] 1-H benzimidazole sodium salt (Figure 1). It has an empirical formula of C18H20N3NaO3S, molecular weight of 381.43, and half-life of 1-2 hour. RPS is a white to yellowish crystalline solid and soluble in water, methanol, and acetonitrile but insoluble in ether and n-hexane. RPS is a substituted benzimidazole which stability is depending on pH. Like most other PPIs, it

References

[1]  D. Pantoflickova, G. Dorta, M. Ravic, P. Jornod, and A. L. Blum, “Acid inhibition on the first day of dosing: comparison of four proton pump inhibitors,” Alimentary Pharmacology and Therapeutics, vol. 17, no. 12, pp. 1507–1514, 2003.
[2]  C. A. Desai and B. D. Samant, “Rabeprazole,” Journal of Postgraduate Medicine, vol. 48, no. 1, pp. 80–81, 2002.
[3]  C. V. Garcia, C. S. Paim, and M. Steppe, “New liquid chromatographic method for determination of rabeprazole sodium in coated tablets,” Journal of AOAC International, vol. 87, no. 4, pp. 842–846, 2004.
[4]  U. M. Karra and S. Yarkala, “A simple and validated reverse phase HPLC method for the determination of rabeprazole in pharmaceutical dosage forms,” E-Journal of Chemistry, vol. 7, no. 2, pp. 569–577, 2010.
[5]  R. Buchireddy, K. Mukkanti, P. Srinivasulu, and K. S. V. Srinivas, “A validated, stability-indicating, LC method for rabeprazole sodium,” Chromatographia, vol. 68, no. 3-4, pp. 275–280, 2008.
[6]  P. R. Battu and M. S. Reddy, “Development and validation of RP-HPLC for the rabeprazole sodium in pharmaceutical formulations and human plasma,” Asian Journal of Research in Chemistry, vol. 2, pp. 49–51, 2009.
[7]  Y. S. Rhee, C. W. Park, Y. S. Shin, S. H. Kam, K. H. Lee, and E. S. Park, “Application of instrumental evaluation of color for the pre-formulation and formulation of rabeprazole,” International Journal of Pharmaceutics, vol. 350, no. 1-2, pp. 122–129, 2008.
[8]  V. G. Cássia, S. N. Norma, S. Martin, and E. S. S. Elfrides, “Structural elucidation of rabeprazole sodium photodegradation products,” Journal of Pharmaceutical and Biomedical Analysis, vol. 46, no. 1, pp. 88–93, 2008.
[9]  M. Miura, H. Tada, S. Satoh, T. Habuchi, and T. Suzuki, “Determination of rabeprazole enantiomers and their metabolites by high-performance liquid chromatography with solid-phase extraction,” Journal of Pharmaceutical and Biomedical Analysis, vol. 41, no. 2, pp. 565–570, 2006.
[10]  A. El-Gindy, F. El-Yazby, and M. M. Maher, “Spectrophotometric and chromatographic determination of rabeprazole in presence of its degradation products,” Journal of Pharmaceutical and Biomedical Analysis, vol. 31, no. 2, pp. 229–242, 2003.
[11]  H. Nakai, Y. Shimamura, T. Kanazawa, S. Yasuda, and M. Kayano, “Determination of a new H+-K+ ATPase inhibitor (E3810) and its four metabolites in human plasma by high-performance Liquid chromatography,” Journal of Chromatography B: Biomedical Applications, vol. 660, no. 1, pp. 211–220, 1994.
[12]  A. A. Shirkhedkar and S. J. Surana, “Application of stability-indicating RP-TLC densitometric determination of rabeprazole sodium in bulk drug and pharmaceutical formulation,” Eurasian Journal of Analytical Chemistry, vol. 4, pp. 87–97, 2009.
[13]  P. B. Raval, M. Puranik, S. J. Wadher, and P. G. Yeole, “A validated HPTLC method for determination of ondansetron in combination with omeprazole or rabeprazole in solid dosage form,” Indian Journal of Pharmaceutical Sciences, vol. 70, no. 3, pp. 386–390, 2008.
[14]  B. H. Patel, B. N. Suhagia, M. M. Patel, and J. R. Patel, “HPTLC determination of rabeprazole and domperidone in capsules and its validation,” Journal of Chromatographic Science, vol. 46, no. 4, pp. 304–307, 2008.
[15]  N. Rahman, Z. Bano, and S. N. H. Azmi, “Quantitative analysis of rabeprazole sodium in commercial dosage forms by spectrophotometry,” Chemical and Pharmaceutical Bulletin, vol. 56, no. 7, pp. 995–1001, 2008.
[16]  D. Madhuri, K. B. Chandrasekhar, M. Ramakotaiah, G. Somasekhar, K. Harinadhababa, and K. R. Kumar, “Validation of spectrophotometric determination of Rabeprazole using ferric chloride (FeCl3),” International Journal of Research in Pharmaceutical Sciences, vol. 1, no. 2, pp. 209–211, 2010.
[17]  M. M. Gouda, S. Somashekar, P. R. Kumar, and S. M. S. Kumar, “Physico-chemical characterization, UV spectrophotometric analytical method development and validation studies of rabeprazole sodium,” Journal of Chemical and Pharmaceutical Research, vol. 2, pp. 187–192, 2010.
[18]  F. Shao, J. Sun, G. Wang, H. Xie, X. Zhu, and J. Zhang, “Liquid chromatographic-mass spectrometry analysis and pharmacokinetic studies of a novel rabeprazole formulation, sterile powder for injection, in dogs and rats,” Biopharmaceutics and Drug Disposition, vol. 28, no. 4, pp. 177–186, 2007.
[19]  A. Radi, N. Abd El-Ghany, and T. Wahdan, “Voltammetric behaviour of rabeprazole at a glassy carbon electrode and its determination in tablet dosage form,” Farmaco, vol. 59, no. 7, pp. 515–518, 2004.
[20]  B. H. Patel, B. N. Suhagia, M. M. Patel, and J. R. Patel, “High-performance liquid chromatography and thin-layer chromatography for the simultaneous quantitation of rabeprazole and mosapride in pharmaceutical products,” Journal of Chromatographic Science, vol. 46, no. 1, pp. 10–14, 2008.
[21]  S. S. Shweta, D. D. Nilesh, Y. J. Vijay, R. T. Santosh, and V. G. Santosh, “Spectrophotometric simultaneous determination of rabeprazole sodium and domperidone in combined tablet dosage form,” Eurasian Journal of Analytical Chemistry, vol. 3, pp. 236–244, 2008.
[22]  ICH, Validation of Analytical Procedures: Text and Methodology Q2 (R1), ICH, Geneva, Switzerland, 1996.
[23]  The United States Pharmacopoeia, 35, NF 30, vol. 1, United States Pharmacopeial Convention, Rockville, Md, USA, 2012.
[24]  U.S. Food and Drug Administration, Dissolution Methods Database, http://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_searchresults_dissolutions.cfm?printall=1.
[25]  Dissolution Testing of Immediate Release Solid Oral Dosage Forms, Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office, Washington, DC, USA, 1997.
[26]  Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations, Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office, Washington, DC, USA, 1997.

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