DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF MICAFUNGIN AND ITS RELATED SUBSTANCES IN BULK BY RP-UPLC
AbstractA gradient reverse phase Ultra Performance Liquid Chromatographic (RP-UPLC) method was developed and validated for determination of Micafungin sodium and its synthetic impurities. The successful separation of Micafungin sodium and its synthetic impurities was achieved using Phenomenax Aeris peptide XB C18 (150×2.1 mm i.d., 1.7 µ particle size) column maintained at 45 °C temperature with mobile phase consisting 0.01 M phosphate buffer pH 2.9 and acetonitrile in a gradient programme. The mobile phase flow rate was 0.3 ml/min and the detection wavelength was 279 nm. The retention time in developed method is comparatively less than the reported HPLC methods for determination of Micafungin sodium offering less time consuming and fast analytical method. The developed RP-UPLC method was validated according to ICH guidelines with respect to linearity, accuracy, precision, specificity and robustness and also the LOD and LOQ values were determined
Article Information
36
1211-18
464
2282
English
IJPSR
Smita Joshi *, Falguni Majmudar and Nirav Vyas
Department of Pharmaceutical Chemistry, K. B. Raval College of Pharmacy, Gandhinagar, Gujarat, India
smita_talaviya85@yahoo.com
16 September, 2015
05 December, 2015
05 January, 2016
10.13040/IJPSR.0975-8232.7(3).1211-18
01 March, 2016
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