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Direct injection, column switching-liquid chromatographic technique for the estimation of rabeprazole in bioequivalence study.
J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Dec 25; 813(1-2):247-54.JC

Abstract

A rapid, simple and sensitive high-performance liquid chromatography-ultra violet (HPLC-UV) method with column switching between sample pre-treatment column and analytical column was developed for the quantitation of rabeprazole in human plasma; on a Bio-Sample Analysis system (Co-sense for BA) from Shimadzu Corporation, Kyoto, Japan. Zaleplon was used as an internal standard. The method was validated as per USFDA guidelines for the concentration range of 20.0-1200.0 ng/mL and the correlation coefficient were found to be better than 0.999. Recovery of rabeprazole as well as the internal standard from human plasma was more than 90.0%. Rabeprazole was stable in human plasma for 4 months at -70 +/- 5 degrees C and for 20.0 h at ambient temperature. In the auto sampler, the drug was stable for 24.0 h at 4 degrees C. The method was specific as there were no interfering peaks in the human plasma eluting at the retention times of the rabeprazole and the internal standard. The frozen plasma samples containing rabeprazole were stable to three freeze thaw cycles. The bioanalytical method was rugged in terms of inter- and intra-day accuracy and precision. The method was simple, specific, sensitive, precise, accurate and suitable for bioequivalence and pharmacokinetic studies. It was successfully applied to the pilot bioequivalence study of 20mg rabeprazole tablet of German Remedies Ltd. (A division of Cadila Healthcare Ltd.), India versus Pariet tablet of Eisai Ltd. & Janssen-Cilag Ltd., Japan in male human subjects.

Authors+Show Affiliations

Singh SS
Zydus Research Centre, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad 382213, India. sonusingh@zyduscadila.com
Jain M
No affiliation info available
Shah H
No affiliation info available
Gupta S
No affiliation info available
Thakker P
No affiliation info available
Shah R
No affiliation info available
Lohray BB
No affiliation info available

MeSH

2-PyridinylmethylsulfinylbenzimidazolesBenzimidazolesCalibrationChromatography, High Pressure LiquidHumansOmeprazoleRabeprazoleReference StandardsReproducibility of ResultsSensitivity and SpecificitySpectrophotometry, UltravioletTherapeutic Equivalency

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15556540

Citation

Singh, Sonu Sundd, et al. "Direct Injection, Column Switching-liquid Chromatographic Technique for the Estimation of Rabeprazole in Bioequivalence Study." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 813, no. 1-2, 2004, pp. 247-54.
Singh SS, Jain M, Shah H, et al. Direct injection, column switching-liquid chromatographic technique for the estimation of rabeprazole in bioequivalence study. J Chromatogr B Analyt Technol Biomed Life Sci. 2004;813(1-2):247-54.
Singh, S. S., Jain, M., Shah, H., Gupta, S., Thakker, P., Shah, R., & Lohray, B. B. (2004). Direct injection, column switching-liquid chromatographic technique for the estimation of rabeprazole in bioequivalence study. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 813(1-2), 247-54.
Singh SS, et al. Direct Injection, Column Switching-liquid Chromatographic Technique for the Estimation of Rabeprazole in Bioequivalence Study. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Dec 25;813(1-2):247-54. PubMed PMID: 15556540.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Direct injection, column switching-liquid chromatographic technique for the estimation of rabeprazole in bioequivalence study. AU - Singh,Sonu Sundd, AU - Jain,Manish, AU - Shah,Hiten, AU - Gupta,Sapna, AU - Thakker,Purav, AU - Shah,Ruchy, AU - Lohray,Braj Bhushan, PY - 2004/04/27/received PY - 2004/09/23/accepted PY - 2004/11/24/pubmed PY - 2005/4/12/medline PY - 2004/11/24/entrez SP - 247 EP - 54 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 813 IS - 1-2 N2 - A rapid, simple and sensitive high-performance liquid chromatography-ultra violet (HPLC-UV) method with column switching between sample pre-treatment column and analytical column was developed for the quantitation of rabeprazole in human plasma; on a Bio-Sample Analysis system (Co-sense for BA) from Shimadzu Corporation, Kyoto, Japan. Zaleplon was used as an internal standard. The method was validated as per USFDA guidelines for the concentration range of 20.0-1200.0 ng/mL and the correlation coefficient were found to be better than 0.999. Recovery of rabeprazole as well as the internal standard from human plasma was more than 90.0%. Rabeprazole was stable in human plasma for 4 months at -70 +/- 5 degrees C and for 20.0 h at ambient temperature. In the auto sampler, the drug was stable for 24.0 h at 4 degrees C. The method was specific as there were no interfering peaks in the human plasma eluting at the retention times of the rabeprazole and the internal standard. The frozen plasma samples containing rabeprazole were stable to three freeze thaw cycles. The bioanalytical method was rugged in terms of inter- and intra-day accuracy and precision. The method was simple, specific, sensitive, precise, accurate and suitable for bioequivalence and pharmacokinetic studies. It was successfully applied to the pilot bioequivalence study of 20mg rabeprazole tablet of German Remedies Ltd. (A division of Cadila Healthcare Ltd.), India versus Pariet tablet of Eisai Ltd. & Janssen-Cilag Ltd., Japan in male human subjects. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/15556540/Direct_injection_column_switching_liquid_chromatographic_technique_for_the_estimation_of_rabeprazole_in_bioequivalence_study_ DB - PRIME DP - Unbound Medicine ER -