Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances
An isocratic, sensitive and stability-indicating high performance liquid chromatographic (HPLC) method for separation and determination of the related substances of micafungin sodium was developed. The chromatographic separation was achieved on Agilent Zorbax SB-C18 column (250 × 4.6 mm, 5 μm). Forc...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2013-10-01
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| Series: | International Journal of Molecular Sciences |
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| Online Access: | http://www.mdpi.com/1422-0067/14/11/21202 |
| _version_ | 1811334826075095040 |
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| author | Zuyue Sun Yongwei Luo Xin Su Xiang Meng Shengsheng Zhu |
| author_facet | Zuyue Sun Yongwei Luo Xin Su Xiang Meng Shengsheng Zhu |
| author_sort | Zuyue Sun |
| collection | DOAJ |
| description | An isocratic, sensitive and stability-indicating high performance liquid chromatographic (HPLC) method for separation and determination of the related substances of micafungin sodium was developed. The chromatographic separation was achieved on Agilent Zorbax SB-C18 column (250 × 4.6 mm, 5 μm). Forced degradation study confirmed that the newly developed method was specific and selective to the degradation products. The performance of the method was validated according to the present ICH guidelines for specificity, linearity, accuracy, precision and robustness. Regression analysis showed correlation coefficient value greater than 0.999 for micafungin sodium and its six impurities. Limit of detection of impurities was in the range of 0.006%–0.013% indicating the high sensitivity of the newly developed method. Accuracy of the method was established based on the recovery obtained between 98.2% and 102.0% for all impurities. RSD obtained for the repeatability and intermediate precision experiments, was less than 1.0%. The method was successfully applied to quantify related substances of micafungin sodium in bulk drugs. |
| first_indexed | 2024-04-13T17:14:55Z |
| format | Article |
| id | doaj.art-bd57fc348bca4c5fad08f63c258bd6e2 |
| institution | Directory Open Access Journal |
| issn | 1422-0067 |
| language | English |
| last_indexed | 2024-04-13T17:14:55Z |
| publishDate | 2013-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | International Journal of Molecular Sciences |
| spelling | doaj.art-bd57fc348bca4c5fad08f63c258bd6e22022-12-22T02:38:10ZengMDPI AGInternational Journal of Molecular Sciences1422-00672013-10-011411212022121410.3390/ijms141121202Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug SubstancesZuyue SunYongwei LuoXin SuXiang MengShengsheng ZhuAn isocratic, sensitive and stability-indicating high performance liquid chromatographic (HPLC) method for separation and determination of the related substances of micafungin sodium was developed. The chromatographic separation was achieved on Agilent Zorbax SB-C18 column (250 × 4.6 mm, 5 μm). Forced degradation study confirmed that the newly developed method was specific and selective to the degradation products. The performance of the method was validated according to the present ICH guidelines for specificity, linearity, accuracy, precision and robustness. Regression analysis showed correlation coefficient value greater than 0.999 for micafungin sodium and its six impurities. Limit of detection of impurities was in the range of 0.006%–0.013% indicating the high sensitivity of the newly developed method. Accuracy of the method was established based on the recovery obtained between 98.2% and 102.0% for all impurities. RSD obtained for the repeatability and intermediate precision experiments, was less than 1.0%. The method was successfully applied to quantify related substances of micafungin sodium in bulk drugs.http://www.mdpi.com/1422-0067/14/11/21202micafungin sodiumrelated substancesstability-indicatingforced degradationvalidation |
| spellingShingle | Zuyue Sun Yongwei Luo Xin Su Xiang Meng Shengsheng Zhu Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances International Journal of Molecular Sciences micafungin sodium related substances stability-indicating forced degradation validation |
| title | Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances |
| title_full | Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances |
| title_fullStr | Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances |
| title_full_unstemmed | Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances |
| title_short | Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances |
| title_sort | development and validation of a stability indicating high performance liquid chromatographic hplc method for the determination of related substances of micafungin sodium in drug substances |
| topic | micafungin sodium related substances stability-indicating forced degradation validation |
| url | http://www.mdpi.com/1422-0067/14/11/21202 |
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