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New liquid chromatographic method for determination of rabeprazole sodium in coated tablets.
J AOAC Int. 2004 Jul-Aug; 87(4):842-6.JA

Abstract

Rabeprazole sodium is a proton pump inhibitor that covalently binds and inactivates the gastric parietal cell proton pump (H+/K+ ATPase). Little has been published about the quantitative determination of this drug. The aim of this research was to develop a new liquid chromatographic method for quantitative determination of rabeprazole in coated tablets. The system consisted of a Hypersil Keystone Betabasic C8 column (250 x 4.6 mm, 5 microm particle size), an isocratic acetonitrile-water (35 + 65) mobile phase at a flow rate of 1.0 mL/min, and a diode array detector set at 282 nm. The following validation parameters were evaluated: linearity, precision, accuracy, specificity, detection and quantitation limits, and robustness. The method showed good linearity in the concentration range of 10-70 microg/mL. The quantitation limit was 2.43 microg/mL, and the detection limit was 0.80 microg/mL. The intra- and interday precision data showed that the method has good reproducibility (relative standard deviation = 1.03). Accuracy and robustness were also evaluated, and the results were satisfactory. The mean recovery was 101.61%. The analysis of a placebo mixture demonstrated the method is also specific.

Authors+Show Affiliations

Universidade Federal do Rio Grande do Sul., Programa de Pós-graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Av. Ipiranga, Porto Alegre/RS CEP, Brazil. cassiavgarcia@yahoo.com.brNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15295877

Citation

Garcia, Cássia V., et al. "New Liquid Chromatographic Method for Determination of Rabeprazole Sodium in Coated Tablets." Journal of AOAC International, vol. 87, no. 4, 2004, pp. 842-6.
Garcia CV, Paim CS, Steppe M. New liquid chromatographic method for determination of rabeprazole sodium in coated tablets. J AOAC Int. 2004;87(4):842-6.
Garcia, C. V., Paim, C. S., & Steppe, M. (2004). New liquid chromatographic method for determination of rabeprazole sodium in coated tablets. Journal of AOAC International, 87(4), 842-6.
Garcia CV, Paim CS, Steppe M. New Liquid Chromatographic Method for Determination of Rabeprazole Sodium in Coated Tablets. J AOAC Int. 2004 Jul-Aug;87(4):842-6. PubMed PMID: 15295877.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - New liquid chromatographic method for determination of rabeprazole sodium in coated tablets. AU - Garcia,Cássia V, AU - Paim,Clésio S, AU - Steppe,Martin, PY - 2004/8/7/pubmed PY - 2004/10/16/medline PY - 2004/8/7/entrez SP - 842 EP - 6 JF - Journal of AOAC International JO - J AOAC Int VL - 87 IS - 4 N2 - Rabeprazole sodium is a proton pump inhibitor that covalently binds and inactivates the gastric parietal cell proton pump (H+/K+ ATPase). Little has been published about the quantitative determination of this drug. The aim of this research was to develop a new liquid chromatographic method for quantitative determination of rabeprazole in coated tablets. The system consisted of a Hypersil Keystone Betabasic C8 column (250 x 4.6 mm, 5 microm particle size), an isocratic acetonitrile-water (35 + 65) mobile phase at a flow rate of 1.0 mL/min, and a diode array detector set at 282 nm. The following validation parameters were evaluated: linearity, precision, accuracy, specificity, detection and quantitation limits, and robustness. The method showed good linearity in the concentration range of 10-70 microg/mL. The quantitation limit was 2.43 microg/mL, and the detection limit was 0.80 microg/mL. The intra- and interday precision data showed that the method has good reproducibility (relative standard deviation = 1.03). Accuracy and robustness were also evaluated, and the results were satisfactory. The mean recovery was 101.61%. The analysis of a placebo mixture demonstrated the method is also specific. SN - 1060-3271 UR - https://www.unboundmedicine.com/medline/citation/15295877/New_liquid_chromatographic_method_for_determination_of_rabeprazole_sodium_in_coated_tablets_ DB - PRIME DP - Unbound Medicine ER -