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Optimization and statistical evaluation of dissolution tests for indinavir sulfate capsules.
Farmaco. 2004 Nov; 59(11):921-7.F

Abstract

An optimization, statistically based on t-student test, to set up dissolution test conditions for indinavir sulfate capsules is presented. Three dissolution media, including that reported in United States Pharmacopeial Forum, and two apparatus, paddle and basket, were applied. Two different indinavir sulfate capsules, products A and B, were evaluated. For a reliable statistical analysis eighteen capsules were assayed in each condition based on the combination of dissolution medium and apparatus. All tested media were statistically equivalent (P > 0.05) for both drug products when paddle apparatus was employed at the stirring speed of 50 rpm. The use of basket apparatus at the stirring speed of 50 rpm caused significant decrease in the drug release percent for the product B (P < 0.05). The best dissolution conditions tested, for products A and B, were applied to evaluate capsules dissolution profiles. Twelve dosage units were assayed and dissolution efficiency concept was used, for each condition, to obtain results with statistical significance (P > 0.05). Optimal conditions to carry out the dissolution test were 900 ml of 0.1 M hydrochloric acid as dissolution medium, basket at 100 rpm stirring speed and 260 nm ultraviolet detection.

Authors+Show Affiliations

Laboratório de Controle de Qualidade de Produtos Farmacêuticos e Cosméticos, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Pampulha 31270-901, Belo Horizonte, MG, Brasil.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15544798

Citation

Carvalho-Silva, B, et al. "Optimization and Statistical Evaluation of Dissolution Tests for Indinavir Sulfate Capsules." Farmaco (Societa Chimica Italiana : 1989), vol. 59, no. 11, 2004, pp. 921-7.
Carvalho-Silva B, Moreira-Campos LM, Nunan EA, et al. Optimization and statistical evaluation of dissolution tests for indinavir sulfate capsules. Farmaco. 2004;59(11):921-7.
Carvalho-Silva, B., Moreira-Campos, L. M., Nunan, E. A., Vianna-Soares, C. D., Araujo-Alves, B. L., Cesar, I. C., & Pianetti, G. A. (2004). Optimization and statistical evaluation of dissolution tests for indinavir sulfate capsules. Farmaco (Societa Chimica Italiana : 1989), 59(11), 921-7.
Carvalho-Silva B, et al. Optimization and Statistical Evaluation of Dissolution Tests for Indinavir Sulfate Capsules. Farmaco. 2004;59(11):921-7. PubMed PMID: 15544798.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Optimization and statistical evaluation of dissolution tests for indinavir sulfate capsules. AU - Carvalho-Silva,B, AU - Moreira-Campos,L M, AU - Nunan,E A, AU - Vianna-Soares,C D, AU - Araujo-Alves,B L, AU - Cesar,I C, AU - Pianetti,G A, PY - 2004/02/24/received PY - 2004/08/07/accepted PY - 2004/11/17/pubmed PY - 2006/1/20/medline PY - 2004/11/17/entrez SP - 921 EP - 7 JF - Farmaco (Societa chimica italiana : 1989) JO - Farmaco VL - 59 IS - 11 N2 - An optimization, statistically based on t-student test, to set up dissolution test conditions for indinavir sulfate capsules is presented. Three dissolution media, including that reported in United States Pharmacopeial Forum, and two apparatus, paddle and basket, were applied. Two different indinavir sulfate capsules, products A and B, were evaluated. For a reliable statistical analysis eighteen capsules were assayed in each condition based on the combination of dissolution medium and apparatus. All tested media were statistically equivalent (P > 0.05) for both drug products when paddle apparatus was employed at the stirring speed of 50 rpm. The use of basket apparatus at the stirring speed of 50 rpm caused significant decrease in the drug release percent for the product B (P < 0.05). The best dissolution conditions tested, for products A and B, were applied to evaluate capsules dissolution profiles. Twelve dosage units were assayed and dissolution efficiency concept was used, for each condition, to obtain results with statistical significance (P > 0.05). Optimal conditions to carry out the dissolution test were 900 ml of 0.1 M hydrochloric acid as dissolution medium, basket at 100 rpm stirring speed and 260 nm ultraviolet detection. SN - 0014-827X UR - https://www.unboundmedicine.com/medline/citation/15544798/Optimization_and_statistical_evaluation_of_dissolution_tests_for_indinavir_sulfate_capsules_ DB - PRIME DP - Unbound Medicine ER -