DETERMINATION OF PINAVERIUM BROMIDE IN PHARMACEUTICAL DOSAGE FORMS BY A VALIDATED STABILITY-INDICATING LC METHOD
A reversed-phase liquid chromatography (LC) method is validated for the determination of pinaverium bromide (PB) in pharmaceutical dosage forms. The LC method is carried out on a reversed-phase monolithic C18 column (100 x 4.6 mm i.d.), maintained at 45 ºC. The mobile phase consisted of acetonitrile...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Universidade Federal do Rio Grande do Sul
2017-08-01
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| Series: | Drug Analytical Research |
| Online Access: | https://seer.ufrgs.br/index.php/produto&producao/ojs/index.php/dar/article/view/73964 |
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| author | Maximiliano da Silva Sangoi Anna Karolina Mouzer da Silva Machado Lorena Coimbra Florindo Brenda Rocha Gonçalves Vítor Todeschini |
| author_facet | Maximiliano da Silva Sangoi Anna Karolina Mouzer da Silva Machado Lorena Coimbra Florindo Brenda Rocha Gonçalves Vítor Todeschini |
| author_sort | Maximiliano da Silva Sangoi |
| collection | DOAJ |
| description | A reversed-phase liquid chromatography (LC) method is validated for the determination of pinaverium bromide (PB) in pharmaceutical dosage forms. The LC method is carried out on a reversed-phase monolithic C18 column (100 x 4.6 mm i.d.), maintained at 45 ºC. The mobile phase consisted of acetonitrile and a solution of triethylamine 0.3% pH 5.0 (50:50; v/v), run at a flow rate of 2.0 mL/min, with photodiode array detector set at 213 nm. The chromatographic separation is obtained with PB retention time of 3.4 min, and it is linear in the range of 5-100 μg/mL (r2 = 0.9991). The limits of detection and quantitation are 1.41 and 4.70 μg/mL, respectively. The specificity and stability-indicating capability of the method are proven through degradation studies, which also showed that there is no interference of the formulation excipients, showing that peak is free from any coeluting peak. The method showed adequate precision, with a relative standard deviation values lower than 1.38%. Excellent values of accuracy were also obtained, with a mean value of 100.68%. Experimental design is used during validation to calculate and prove method robustness. The proposed LC method is applied for the analysis of the PB pharmaceutical dosage forms, contributing to improve the quality control and to assure the therapeutic efficacy. |
| first_indexed | 2024-03-08T02:05:01Z |
| format | Article |
| id | doaj.art-98ad0f262b4c4740ae0e9f894949646f |
| institution | Directory Open Access Journal |
| issn | 2527-2616 |
| language | English |
| last_indexed | 2024-03-08T02:05:01Z |
| publishDate | 2017-08-01 |
| publisher | Universidade Federal do Rio Grande do Sul |
| record_format | Article |
| series | Drug Analytical Research |
| spelling | doaj.art-98ad0f262b4c4740ae0e9f894949646f2024-02-13T18:15:12ZengUniversidade Federal do Rio Grande do SulDrug Analytical Research2527-26162017-08-0111DETERMINATION OF PINAVERIUM BROMIDE IN PHARMACEUTICAL DOSAGE FORMS BY A VALIDATED STABILITY-INDICATING LC METHODMaximiliano da Silva Sangoi0Anna Karolina Mouzer da Silva Machado1Lorena Coimbra Florindo2Brenda Rocha Gonçalves3Vítor Todeschini4Laboratory of Pharmaceutical Analysis, Faculty of Pharmacy, Federal University of Rio de JaneiroLaboratory of Pharmaceutical Analysis, Faculty of Pharmacy, Federal University of Rio de JaneiroLaboratory of Pharmaceutical Analysis, Faculty of Pharmacy, Federal University of Rio de JaneiroLaboratory of Pharmaceutical Analysis, Faculty of Pharmacy, Federal University of Rio de JaneiroLaboratory of Pharmaceutical Analysis, Faculty of Pharmacy, Federal University of Rio de JaneiroA reversed-phase liquid chromatography (LC) method is validated for the determination of pinaverium bromide (PB) in pharmaceutical dosage forms. The LC method is carried out on a reversed-phase monolithic C18 column (100 x 4.6 mm i.d.), maintained at 45 ºC. The mobile phase consisted of acetonitrile and a solution of triethylamine 0.3% pH 5.0 (50:50; v/v), run at a flow rate of 2.0 mL/min, with photodiode array detector set at 213 nm. The chromatographic separation is obtained with PB retention time of 3.4 min, and it is linear in the range of 5-100 μg/mL (r2 = 0.9991). The limits of detection and quantitation are 1.41 and 4.70 μg/mL, respectively. The specificity and stability-indicating capability of the method are proven through degradation studies, which also showed that there is no interference of the formulation excipients, showing that peak is free from any coeluting peak. The method showed adequate precision, with a relative standard deviation values lower than 1.38%. Excellent values of accuracy were also obtained, with a mean value of 100.68%. Experimental design is used during validation to calculate and prove method robustness. The proposed LC method is applied for the analysis of the PB pharmaceutical dosage forms, contributing to improve the quality control and to assure the therapeutic efficacy.https://seer.ufrgs.br/index.php/produto&producao/ojs/index.php/dar/article/view/73964 |
| spellingShingle | Maximiliano da Silva Sangoi Anna Karolina Mouzer da Silva Machado Lorena Coimbra Florindo Brenda Rocha Gonçalves Vítor Todeschini DETERMINATION OF PINAVERIUM BROMIDE IN PHARMACEUTICAL DOSAGE FORMS BY A VALIDATED STABILITY-INDICATING LC METHOD Drug Analytical Research |
| title | DETERMINATION OF PINAVERIUM BROMIDE IN PHARMACEUTICAL DOSAGE FORMS BY A VALIDATED STABILITY-INDICATING LC METHOD |
| title_full | DETERMINATION OF PINAVERIUM BROMIDE IN PHARMACEUTICAL DOSAGE FORMS BY A VALIDATED STABILITY-INDICATING LC METHOD |
| title_fullStr | DETERMINATION OF PINAVERIUM BROMIDE IN PHARMACEUTICAL DOSAGE FORMS BY A VALIDATED STABILITY-INDICATING LC METHOD |
| title_full_unstemmed | DETERMINATION OF PINAVERIUM BROMIDE IN PHARMACEUTICAL DOSAGE FORMS BY A VALIDATED STABILITY-INDICATING LC METHOD |
| title_short | DETERMINATION OF PINAVERIUM BROMIDE IN PHARMACEUTICAL DOSAGE FORMS BY A VALIDATED STABILITY-INDICATING LC METHOD |
| title_sort | determination of pinaverium bromide in pharmaceutical dosage forms by a validated stability indicating lc method |
| url | https://seer.ufrgs.br/index.php/produto&producao/ojs/index.php/dar/article/view/73964 |
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