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Development and validation of a dissolution test for rabeprazole sodium in coated tablets.
J Pharm Biomed Anal. 2006 Jun 07; 41(3):833-7.JP

Abstract

The aim of this work is to develop and validate a dissolution test for rabeprazole sodium coated tablets using a reverse-phase liquid chromatographic method. After test sink conditions, dissolution medium and stability of the drug, the best conditions were: paddle at 75 rotations per minute (rpm) stirring speed, HCl 0.1 M and borate buffer pH 9.0 as dissolution medium for acidic and basic steps, respectively, volume of 900 ml for both. The quantitation method was also adapted and validated. Less than 10% of the label amount was released in the acid step, while more than 95% was achieved over 30 min in the basic one. The dissolution profile for tablets was considered satisfactory. The dissolution test developed was adequate for its purpose and could be applied for quality control of rabeprazole tablets, since there is no official monograph.

Authors+Show Affiliations

Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul., Av. Ipiranga, 2752 Lab. 402, Porto Alegre/RS, CEP 90610-000, Brazil. cassiavgarcia@yahoo.com.brNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16513316

Citation

Garcia, Cassia V., et al. "Development and Validation of a Dissolution Test for Rabeprazole Sodium in Coated Tablets." Journal of Pharmaceutical and Biomedical Analysis, vol. 41, no. 3, 2006, pp. 833-7.
Garcia CV, Paim CS, Steppe M, et al. Development and validation of a dissolution test for rabeprazole sodium in coated tablets. J Pharm Biomed Anal. 2006;41(3):833-7.
Garcia, C. V., Paim, C. S., Steppe, M., & Schapoval, E. E. (2006). Development and validation of a dissolution test for rabeprazole sodium in coated tablets. Journal of Pharmaceutical and Biomedical Analysis, 41(3), 833-7.
Garcia CV, et al. Development and Validation of a Dissolution Test for Rabeprazole Sodium in Coated Tablets. J Pharm Biomed Anal. 2006 Jun 7;41(3):833-7. PubMed PMID: 16513316.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of a dissolution test for rabeprazole sodium in coated tablets. AU - Garcia,Cassia V, AU - Paim,Clesio S, AU - Steppe,Martin, AU - Schapoval,Elfrides E S, Y1 - 2006/03/02/ PY - 2005/08/18/received PY - 2006/01/23/revised PY - 2006/01/25/accepted PY - 2006/3/4/pubmed PY - 2006/8/2/medline PY - 2006/3/4/entrez SP - 833 EP - 7 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 41 IS - 3 N2 - The aim of this work is to develop and validate a dissolution test for rabeprazole sodium coated tablets using a reverse-phase liquid chromatographic method. After test sink conditions, dissolution medium and stability of the drug, the best conditions were: paddle at 75 rotations per minute (rpm) stirring speed, HCl 0.1 M and borate buffer pH 9.0 as dissolution medium for acidic and basic steps, respectively, volume of 900 ml for both. The quantitation method was also adapted and validated. Less than 10% of the label amount was released in the acid step, while more than 95% was achieved over 30 min in the basic one. The dissolution profile for tablets was considered satisfactory. The dissolution test developed was adequate for its purpose and could be applied for quality control of rabeprazole tablets, since there is no official monograph. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/16513316/Development_and_validation_of_a_dissolution_test_for_rabeprazole_sodium_in_coated_tablets_ DB - PRIME DP - Unbound Medicine ER -