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Validation of an HPLC-MS method for rociverine tablet dissolution analysis.
J Pharm Biomed Anal. 2008 Jun 09; 47(2):422-8.JP

Abstract

The aim of this work was to develop and validate a method to assess the dissolution behaviour of rociverine sugar-coated tablets. In our laboratories, an HPLC-MS in reverse phase method of analysis was developed for the dosage of unknown rociverine solution. This analytical method was applied to determine the dissolution rate of rociverine tablets produced by the industrial procedure, because there is no official method description. Dissolution tests were carried out in sink conditions as follows: dissolution medium HCl 0.01 N, paddle rotation speed 50 rpm and vessel volume 1000 ml. The dissolution test gave satisfactory results: 95% of the drug was dissolved within 30 min and drug dissolution was concluded after 60 min. The method was demonstrated to be adequate for Quality Control of rociverine tablets. Validation was inferred from specificity, linearity, precision, accuracy and robustness.

Authors+Show Affiliations

University of Tirana, Department of Pharmacy, Rr Dibres, Albania.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18295427

Citation

Hoti, Ela, et al. "Validation of an HPLC-MS Method for Rociverine Tablet Dissolution Analysis." Journal of Pharmaceutical and Biomedical Analysis, vol. 47, no. 2, 2008, pp. 422-8.
Hoti E, Censi R, Ricciutelli M, et al. Validation of an HPLC-MS method for rociverine tablet dissolution analysis. J Pharm Biomed Anal. 2008;47(2):422-8.
Hoti, E., Censi, R., Ricciutelli, M., Malaj, L., Barboni, L., Martelli, S., Valleri, M., & Di Martino, P. (2008). Validation of an HPLC-MS method for rociverine tablet dissolution analysis. Journal of Pharmaceutical and Biomedical Analysis, 47(2), 422-8. https://doi.org/10.1016/j.jpba.2008.01.009
Hoti E, et al. Validation of an HPLC-MS Method for Rociverine Tablet Dissolution Analysis. J Pharm Biomed Anal. 2008 Jun 9;47(2):422-8. PubMed PMID: 18295427.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of an HPLC-MS method for rociverine tablet dissolution analysis. AU - Hoti,Ela, AU - Censi,Roberta, AU - Ricciutelli,Massimo, AU - Malaj,Ledjan, AU - Barboni,Luciano, AU - Martelli,Sante, AU - Valleri,Maurizio, AU - Di Martino,Piera, Y1 - 2008/01/16/ PY - 2007/06/25/received PY - 2007/12/21/revised PY - 2008/01/03/accepted PY - 2008/2/26/pubmed PY - 2008/7/30/medline PY - 2008/2/26/entrez SP - 422 EP - 8 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 47 IS - 2 N2 - The aim of this work was to develop and validate a method to assess the dissolution behaviour of rociverine sugar-coated tablets. In our laboratories, an HPLC-MS in reverse phase method of analysis was developed for the dosage of unknown rociverine solution. This analytical method was applied to determine the dissolution rate of rociverine tablets produced by the industrial procedure, because there is no official method description. Dissolution tests were carried out in sink conditions as follows: dissolution medium HCl 0.01 N, paddle rotation speed 50 rpm and vessel volume 1000 ml. The dissolution test gave satisfactory results: 95% of the drug was dissolved within 30 min and drug dissolution was concluded after 60 min. The method was demonstrated to be adequate for Quality Control of rociverine tablets. Validation was inferred from specificity, linearity, precision, accuracy and robustness. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/18295427/Validation_of_an_HPLC_MS_method_for_rociverine_tablet_dissolution_analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(08)00029-0 DB - PRIME DP - Unbound Medicine ER -