Optimized analysis for related substances in spiramycin based on high performance liquid chromatography with hybrid particle column and characterization of its impurities by single heartcut two-dimensional liquid chromatography coupled with quadrupole time-of-flight mass spectrometer.
J Pharm Biomed Anal
; 252: 116486, 2024 Sep 24.
Article
in En
| MEDLINE
| ID: mdl-39326378
ABSTRACT
This article described the development and validation of a method for spiramycin related substances based on hybrid particle column. The chromatographic conditions were as follows water - 0.2â¯mol/L dipotassium hydrogen phosphate (the pH value adjusted to 9.5 using a 1â¯mol/L KOH solution) - acetonitrile - methanol (10 60 28.5 1.5, v/v/v/v) as mobile phase A, water - 0.2â¯mol/L dipotassium hydrogen phosphate (pH 9.5) - acetonitrile - methanol (10 30 57 3, v/v/v/v) as mobile phase B and gradient elution was performed. Compared with previous analytical methods, this method has strong specificity, excellent sensitivity and stability, which could be used for the daily testing of related substances of spiramycin. Furthermore, impurities above 0.1â¯% were characterized using two-dimensional liquid chromatography coupled with quadrupole time-of-flight mass spectrometer (2D LC-QTOF-MS/MS) and there were 6 impurities reported for the first time.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Language:
En
Journal:
J Pharm Biomed Anal
Year:
2024
Document type:
Article
Affiliation country:
China
Country of publication:
Reino Unido