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.
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.
authors.affiliation: School of Pharmacy, Fudan University. Shanghai 200032, China. sunzy64@163.com.
authors.forename: Shengsheng
authors.initials: S
authors.lastname: Zhu
authors.forename: Xiang
authors.initials: X
authors.lastname: Meng
authors.forename: Xin
authors.initials: X
authors.lastname: Su
authors.forename: Yongwei
authors.initials: Y
authors.lastname: Luo
authors.forename: Zuyue
authors.initials: Z
authors.lastname: Sun
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D054714:Echinocandins / Q000737:chemistry / Q000302:isolation & purification* / Q000627:therapeutic use; D006801:Humans; D055666:Lipopeptides / Q000737:chemistry / Q000302:isolation & purification* / Q000627:therapeutic use; D000077551:Micafungin; D015394:Molecular Structure; D012680:Sensitivity and Specificity
chemical_list: D054714:Echinocandins; D055666:Lipopeptides; D000077551:Micafungin