Determination of Related Substances in Rifabutin Crude Drug and Capsules by HPLC
- VernacularTitle:HPLC法测定利福布汀原料药及胶囊中有关物质
- Author:
Qiuyan YI
1
;
Xuewen CUI
1
;
Jun LUO
2
;
Wenyue LIU
2
;
Jun YUAN
1
Author Information
1. Microbial Center,Sichuan Institute for Food and Drug Control,Chengdu 611731,China
2. Quality Department,Sichuan Med-shine Pharmaceutical Co.Ltd.,Chengdu 611130,China
- Publication Type:Journal Article
- Keywords:
Rifabutin;
Related substances;
HPLC;
Crude drug;
Capsules
- From:
China Pharmacy
2019;30(15):2047-2051
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To establish a method for the determination of related substances in rifabutin crude drug and capsules by HPLC. METHODS: HPLC method was adopted. The determination was performed on Agilent XDB-C8 column with mobile phase consisted of acetonitrile-0.1 mol/L potassium dihydrogen phosphate solution (pH 6.5±0.1) (50 ∶ 50, V/V) at the flow rate of 1.0 mL/min. The detection wavelength was set at 254 nm, the column temperature was 30 ℃, and sample size was 20 μL. The mobile phase was used as solvent to prepare the sample solution with a mass concentration of 1.0 mg/mL. The system suitability test was performed by using newly established method and current method (mass concentration of sample solution 0.5 mg/mL, C18 column) stated in quality standard of rifabutin crude drug and capsules. Related substance test was conducted for 6 batches of rifabutin crude drug and capsule (peak area normalization method). RESULTS: The linear range of rifabutin was 0.8-16 μg/mL(r=1.000 0), RSDs of precision, reproducibility and stability tests (12 h) were all lower than 2.0% (n=6); the limits of detection and quantification were 0.025 4, 0.085 2 μg/mL. In system suitability test, by using new method and current method, separation degree of rifabutin peak and pre-degradation product peak were 7.50 and 3.47. When 6 batches of samples were determined, the number of impurities detected by this method was 1-5 more than that by the current method, and the total amount of impurities was 0.19%-0.55% higher. CONCLUSIONS: Established new method is well-separated and sensitive, and can be used for the determination of related substance in rifabutin crude drug and capsules, which helps the quality control of drugs.