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Int. J. Mol. Sci. 2013, 14(11), 21202-21214; doi:10.3390/ijms141121202
Article

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

1,2
,
1,2
,
1,2
,
1,2
 and
2,*
1 School of Pharmacy, Fudan University. Shanghai 200032, China 2 Department of Pharmacology and Toxicology, Shanghai Institute of Planned Parenthood Research, Shanghai 200032, China
* Author to whom correspondence should be addressed.
Received: 26 September 2013 / Revised: 15 October 2013 / Accepted: 16 October 2013 / Published: 24 October 2013
(This article belongs to the Section Biochemistry, Molecular Biology and Biophysics)
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Abstract

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.
Keywords: micafungin sodium; related substances; stability-indicating; forced degradation; validation micafungin sodium; related substances; stability-indicating; forced degradation; validation
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Zhu, S.; Meng, X.; Su, X.; Luo, Y.; Sun, Z. 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. Int. J. Mol. Sci. 2013, 14, 21202-21214.

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