Qualitative and quantitative assessment of related substances in the Compound Ketoconazole and Clobetasol Propionate Cream by HPLC-TOF-MS and HPLC
- Author:
Wenling YANG
1
;
Xiaomei YANG
;
Fanghua SHI
;
Zhigang LIAO
;
Yongkun LIANG
;
Liangzhong YU
;
Ruixun WANG
;
Qing LI
;
Kaishun BI
Author Information
1. School of Pharmacy
- Keywords:
Compound Ketoconazole and Clobetasol;
Propionate Cream;
Ketoconazole impurity B' optical isomer;
Ketoconazole impurity E;
Quality control;
HPLC-TOF-MS;
HPLC
- From:
Journal of Pharmaceutical Analysis
2019;9(3):156-162
- CountryChina
- Language:Chinese
-
Abstract:
Related substances in pharmaceutical formulations are associated with their safety, efficacy and stability. However, there is no overall study already published on the assessment of related substances in the Compound Ketoconazole and Clobetasol Propionate Cream. In this work, a reliable HPLC-TOF-MS qua-litative method was developed for the analysis of related substances in this preparation with a quick and easy extraction procedure. Besides the active pharmaceutical ingredients, two compounds named ke-toconazole impurity B′ optical isomer and ketoconazole impurity E were identified. Furthermore, a new HPLC method for qualitative and quantitative assessment on related substances and degradation pro-ducts, which were found in the stability test, was established and validated. The single standard to determine multi-components method was applied in the quantitative analysis, which was an effective way for reducing cost and improving accuracy. This study can provide a creative idea for routine analysis of quality control of the Compound Ketoconazole and Clobetasol Propionate Cream.
