Determination of the Polymers in Meropenem for Injection by Size Exclusion Chromatography(HPSCE) and Evaluation of Drug Quality
- Author:
Ai-Ying KONG
1
Author Information
- Publication Type:Journal Article
- Keywords: Meropenem; Polymers; TSKgel G2000SWXL chromatography column
- From: Chinese Pharmaceutical Journal 2019;54(19):1611-1616
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To establish a size exclusion chromatography(HPSCE) method for the determination of the polymers in meropenem for injection. METHODS: The analysis was carried out using a TSKgel G2000SWXL column(7.8 mm×30 cm, 5 μm). The mobile phase was pH 7.0 phosphate buffer solution(0.005 mol•L-1 disodium hydrogen orthophosphate-0.005 mol•L-1 sodium dihydrogen phosphate, 61:39, V/V). The flow rate was 0.8 mL•min-1. The detection wavelength was 254 nm. The column temperature was 25 ℃. RESULTS: The polymers were completely separated from meropenem. The calibration curve of meropenem was linear within the range of 2.54-50.83 μg•mL-1(r=0.999 6, n=6). The specificity of the HPSEC was checked by switching the effluent of each peak on the GFC to a C18 column and analyzing the effluent by LC-MS. CONCLUSION: This method is simple, accurate, sensitive, reliable and applicable for the determination of the polymers of meropenem, and can be applied to the drug quality evaluation.
