Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC
The present work describes development and validation of a specific, sensitive, precise and stability-indicating high-performance liquid chromatographic method of analysis of atorvastatin calcium and celecoxib, both as a bulk drug and in niosomal formulation. The analysis has been performed by using...
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| Format: | Article |
| Language: | English |
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Universidade de São Paulo
2015-09-01
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000300653&lng=en&tlng=en |
| _version_ | 1818383307046387712 |
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| author | Priyanka S. Jadhav Priti M. Jamkar Amelia M. Avachat |
| author_facet | Priyanka S. Jadhav Priti M. Jamkar Amelia M. Avachat |
| author_sort | Priyanka S. Jadhav |
| collection | DOAJ |
| description | The present work describes development and validation of a specific, sensitive, precise and stability-indicating high-performance liquid chromatographic method of analysis of atorvastatin calcium and celecoxib, both as a bulk drug and in niosomal formulation. The analysis has been performed by using Cosmosil-C18 column (4.6 mm´250 mm, 5 m) at 25 °C using acetonitrile: ammonium acetate buffer pH 5.0: methanol (50:25:25 v/v/v) as mobile phase. The detection was carried out at 277nm with a flow rate of 1.0mL/min. The retention times of Atorvastatin calcium and Celecoxib were 6.195 and 3.989min, respectively. The method was validated according to ICH guidelines, for specificity, precision, linearity, accuracy and robustness. Atorvastatin calcium and Celecoxib were subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation was observed in oxidation and acid hydrolysis. The linearity for atorvastatin calcium and celecoxib were in the range of 100-500 µg/mL. The recovery study of atorvastatin and celecoxib were found to be in the range of 98.96 - 99.92% and 98.90-100%, respectively. The proposed method was validated and successfully applied to the estimation of Atorvastatin calcium and Celecoxib in combined in-house niosomal formulation. |
| first_indexed | 2024-12-14T03:04:17Z |
| format | Article |
| id | doaj.art-f251478a56934cd7878c672b4017ed71 |
| institution | Directory Open Access Journal |
| issn | 2175-9790 |
| language | English |
| last_indexed | 2024-12-14T03:04:17Z |
| publishDate | 2015-09-01 |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-f251478a56934cd7878c672b4017ed712022-12-21T23:19:27ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-97902015-09-0151365366110.1590/S1984-82502015000300017S1984-82502015000300653Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLCPriyanka S. JadhavPriti M. JamkarAmelia M. AvachatThe present work describes development and validation of a specific, sensitive, precise and stability-indicating high-performance liquid chromatographic method of analysis of atorvastatin calcium and celecoxib, both as a bulk drug and in niosomal formulation. The analysis has been performed by using Cosmosil-C18 column (4.6 mm´250 mm, 5 m) at 25 °C using acetonitrile: ammonium acetate buffer pH 5.0: methanol (50:25:25 v/v/v) as mobile phase. The detection was carried out at 277nm with a flow rate of 1.0mL/min. The retention times of Atorvastatin calcium and Celecoxib were 6.195 and 3.989min, respectively. The method was validated according to ICH guidelines, for specificity, precision, linearity, accuracy and robustness. Atorvastatin calcium and Celecoxib were subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation was observed in oxidation and acid hydrolysis. The linearity for atorvastatin calcium and celecoxib were in the range of 100-500 µg/mL. The recovery study of atorvastatin and celecoxib were found to be in the range of 98.96 - 99.92% and 98.90-100%, respectively. The proposed method was validated and successfully applied to the estimation of Atorvastatin calcium and Celecoxib in combined in-house niosomal formulation.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000300653&lng=en&tlng=enAtorvastatina cálcica/determinaçãoCelecoxibe/determinaçãoCromatografia líquida de alta eficiência/controle de qualidade Formulação de niosomal/controle de qualidadeFormulações farmacêuticas/controle de qualidade |
| spellingShingle | Priyanka S. Jadhav Priti M. Jamkar Amelia M. Avachat Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC Brazilian Journal of Pharmaceutical Sciences Atorvastatina cálcica/determinação Celecoxibe/determinação Cromatografia líquida de alta eficiência/controle de qualidade Formulação de niosomal/controle de qualidade Formulações farmacêuticas/controle de qualidade |
| title | Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC |
| title_full | Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC |
| title_fullStr | Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC |
| title_full_unstemmed | Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC |
| title_short | Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC |
| title_sort | stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by rp hplc |
| topic | Atorvastatina cálcica/determinação Celecoxibe/determinação Cromatografia líquida de alta eficiência/controle de qualidade Formulação de niosomal/controle de qualidade Formulações farmacêuticas/controle de qualidade |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000300653&lng=en&tlng=en |
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