A novel method for the determination of chemical purity and assay of menaquinone-7. Comparison with the methods from the official USP monograph
详细信息 查看全文
- 作者：Łukasz Jedynak ; l.jedynak@ifarm.eu ; Maria Jedynak ; Magdalena Kossykowska ; Joanna Zagrodzka
- 关键词：Menaquinone-7 ; Chemical purity ; Assay ; HPLC ; Degradation studies
- 刊名：Journal of Pharmaceutical and Biomedical Analysis
- 出版年：2017
- 出版时间：20 February 2017
- 年：2017
- 卷：135
- 期：Complete
- 页码：116-125
- 全文大小：1497 K
- 卷排序：135
文摘
HPLC UV method for simultaneous determination of MK7 purity and assay was developed. The proposed methodology can be applied for MK7 samples of different purity. Low time, solvent and sample consumption, high selectivity and accuracy of the method. The method is superior to the methods published in the USP Monograph. The use of USP methodology leads to serious overestimation of MK7 purity and assay.