STABILITY-INDICATING LC METHOD FOR THE QUANTIFICATION OF MIDAZOLAM ACTIVE PHARMACEUTICAL INGREDIENT AND IN PHARMACEUTICAL FORMULATIONS
A stability-indicating LC method was validated for the quantification of midazolam (MDZ) active pharmaceutical ingredient (API) and in pharmaceutical formulations. Isocratic chromatography was performed on C18 column with mobile phase containing methanol/acetonitrile/water (45:35:20 v/v/v) with 0.4...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Universidade Federal do Rio Grande do Sul
2018-12-01
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| Series: | Drug Analytical Research |
| Online Access: | https://seer.ufrgs.br/index.php/produto&producao/ojs/include/index.php/dar/article/view/86375 |
| _version_ | 1797388924733095936 |
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| author | Daiane Anzilaggo Bádila Regina Dalla Costa Luciana Grazziotin Rossato-Grando Hellen Karine Stulzer Charise Dallazem Bertol |
| author_facet | Daiane Anzilaggo Bádila Regina Dalla Costa Luciana Grazziotin Rossato-Grando Hellen Karine Stulzer Charise Dallazem Bertol |
| author_sort | Daiane Anzilaggo |
| collection | DOAJ |
| description |
A stability-indicating LC method was validated for the quantification of midazolam (MDZ) active pharmaceutical ingredient (API) and in pharmaceutical formulations. Isocratic chromatography was performed on C18 column with mobile phase containing methanol/acetonitrile/water (45:35:20 v/v/v) with 0.4% of triethylamine pH 6.5. The validation included specificity, linearity, accuracy, precision and robustness. In specificity, after acid, basic, neutral, oxidant and thermal degradation, it was found that the concentration of MDZ decreased substantially, with the appearance of peaks representatives of the degradation products, proving the stability-indicating power of the method. The response was linear in the range 50.0 – 250.0 µg.mL-1, with 11.73 µg.mL-1 and 3.87 µg.mL-1 as LOQ and LOD, respectively. Recoveries ranged between 98.68 and 100.41%. The relative standard deviation values for intra and interday precision were 1.11%, 0.82% and 1.47%, respectively. The tablets and injections containing MDZ were approved in the assay and content uniformity. The method can be adopted by pharmacopeias and for routine quality control for analysis of MDZ API, tablets and injection.
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| first_indexed | 2024-03-08T22:47:54Z |
| format | Article |
| id | doaj.art-1835ebeda0074fbd830a4f9a4a60a77c |
| institution | Directory Open Access Journal |
| issn | 2527-2616 |
| language | English |
| last_indexed | 2024-03-08T22:47:54Z |
| publishDate | 2018-12-01 |
| publisher | Universidade Federal do Rio Grande do Sul |
| record_format | Article |
| series | Drug Analytical Research |
| spelling | doaj.art-1835ebeda0074fbd830a4f9a4a60a77c2023-12-16T18:13:56ZengUniversidade Federal do Rio Grande do SulDrug Analytical Research2527-26162018-12-0122STABILITY-INDICATING LC METHOD FOR THE QUANTIFICATION OF MIDAZOLAM ACTIVE PHARMACEUTICAL INGREDIENT AND IN PHARMACEUTICAL FORMULATIONSDaiane Anzilaggo0Bádila Regina Dalla Costa1Luciana Grazziotin Rossato-Grando2Hellen Karine Stulzer3Charise Dallazem Bertol4Universidade de Passo Fundo Universidade Federal de Santa CatarinaUniversidade de Passo FundoUniversidade de Passo FundoUniversidade Federal de Santa CatarinaUniversidade de Passo Fundo A stability-indicating LC method was validated for the quantification of midazolam (MDZ) active pharmaceutical ingredient (API) and in pharmaceutical formulations. Isocratic chromatography was performed on C18 column with mobile phase containing methanol/acetonitrile/water (45:35:20 v/v/v) with 0.4% of triethylamine pH 6.5. The validation included specificity, linearity, accuracy, precision and robustness. In specificity, after acid, basic, neutral, oxidant and thermal degradation, it was found that the concentration of MDZ decreased substantially, with the appearance of peaks representatives of the degradation products, proving the stability-indicating power of the method. The response was linear in the range 50.0 – 250.0 µg.mL-1, with 11.73 µg.mL-1 and 3.87 µg.mL-1 as LOQ and LOD, respectively. Recoveries ranged between 98.68 and 100.41%. The relative standard deviation values for intra and interday precision were 1.11%, 0.82% and 1.47%, respectively. The tablets and injections containing MDZ were approved in the assay and content uniformity. The method can be adopted by pharmacopeias and for routine quality control for analysis of MDZ API, tablets and injection. https://seer.ufrgs.br/index.php/produto&producao/ojs/include/index.php/dar/article/view/86375 |
| spellingShingle | Daiane Anzilaggo Bádila Regina Dalla Costa Luciana Grazziotin Rossato-Grando Hellen Karine Stulzer Charise Dallazem Bertol STABILITY-INDICATING LC METHOD FOR THE QUANTIFICATION OF MIDAZOLAM ACTIVE PHARMACEUTICAL INGREDIENT AND IN PHARMACEUTICAL FORMULATIONS Drug Analytical Research |
| title | STABILITY-INDICATING LC METHOD FOR THE QUANTIFICATION OF MIDAZOLAM ACTIVE PHARMACEUTICAL INGREDIENT AND IN PHARMACEUTICAL FORMULATIONS |
| title_full | STABILITY-INDICATING LC METHOD FOR THE QUANTIFICATION OF MIDAZOLAM ACTIVE PHARMACEUTICAL INGREDIENT AND IN PHARMACEUTICAL FORMULATIONS |
| title_fullStr | STABILITY-INDICATING LC METHOD FOR THE QUANTIFICATION OF MIDAZOLAM ACTIVE PHARMACEUTICAL INGREDIENT AND IN PHARMACEUTICAL FORMULATIONS |
| title_full_unstemmed | STABILITY-INDICATING LC METHOD FOR THE QUANTIFICATION OF MIDAZOLAM ACTIVE PHARMACEUTICAL INGREDIENT AND IN PHARMACEUTICAL FORMULATIONS |
| title_short | STABILITY-INDICATING LC METHOD FOR THE QUANTIFICATION OF MIDAZOLAM ACTIVE PHARMACEUTICAL INGREDIENT AND IN PHARMACEUTICAL FORMULATIONS |
| title_sort | stability indicating lc method for the quantification of midazolam active pharmaceutical ingredient and in pharmaceutical formulations |
| url | https://seer.ufrgs.br/index.php/produto&producao/ojs/include/index.php/dar/article/view/86375 |
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