New liquid chromatographic method for determination of rabeprazole sodium in coated tablets.
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.
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.br
Cássia V
CV
Garcia
Clésio S
CS
Paim
Martin
M
Steppe
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents / Q000032:analysis*; D001562:Benzimidazoles / Q000032:analysis*; D002853:Chromatography, Liquid; D005079:Excipients; D007202:Indicators and Reagents; D009853:Omeprazole / Q000031:analogs & derivatives; D064750:Rabeprazole; D012015:Reference Standards; D015203:Reproducibility of Results; D012984:Software; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D005079:Excipients; D007202:Indicators and Reagents; D013607:Tablets; D064750:Rabeprazole; D009853:Omeprazole