Analytical Quality by Design-Based Development and Validation of Ultra Pressure Liquid Chromatography/MS/MS Method for Glycopeptide Antibiotics Determination in Human Plasma

Abstract

Aim: An ultra pressure liquid chromatography (UPLC)/MS/MS method for vancomycin and teicoplanin determination in human plasma was developed in accordance with analytical quality by design (AQbD) concept and fully validated. Materials & methods: Chromatographic separation was performed on ACQUITY UPLC C18 charge surface hybrid (CSH) column (2.1 mm × 50 mm, 1.7 μm particle size) in gradient mode and the mobile phase consisted of 0.1% formic acid in water and pure acetonitrile. The experimental design methodology was used for the definition of optimal chromatographic and protein precipitation conditions. Results: The linearity ranges were 0.05–10 μg ml-1 for vancomycin and 0.5–200 μg ml-1 for total teicoplanin. The relative standard deviations for precision estimation were below 15% and the accuracy was within 85–115% for all quality control levels. Conclusion: The method was utilized for glycopeptide antibiotics bioanalysis.

An Overview of Analytical Methodologies for Determination of Vancomycin in Human Plasma

“…Therefore, isotopically labeled vancomycin with similar extraction recovery, chromatographic characteristics, and ionization response to the desired analyte are the preferred choice of IS for MS detection for commercialization and the most applied vancomycin derivatives in the studies were vancomycin derivatives such as desmethyl vancomycin [ 51 , 52 , 54 ], desleucine vancomycin [ 58 ], and vancomycin-glycin [ 61 ], all of which have similar features to the isotope-labeled vancomycin. Others such as tobramycin [ 22 ], PABA [ 46 ], erythromycin [ 48 ], roxithromycin [ 53 ], linezolid [ 55 ], 10-hydroxycarbazepine [ 56 ], atenolol [ 59 ], 13C3-caffeine [ 60 ], polymyxin B [ 62 ], and kanamycin B [ 64 ] were confirmed to be applied as IS in the study.…”

“…LC is an essential method for isolating and detecting vancomycin in plasma or serum. Table 3 reviews the methods and chromatographic analysis conditions for determining vancomycin in human plasma or serum [ 21 , 22 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 ]. Undeniably, LC can analyze different body fluids such as plasma, serum, urine, cerebrospinal fluid, alveolar lavage fluid, atrial fluid, and other drug components or drug solutions prepared with different solvents.…”

“…In the LC method, pretreatment is conducted to eliminate interference from plasma proteins and other macromolecular substances. All samples were physically separated by centrifugation, and most studies added precipitates to denature the protein [ 21 , 22 , 34 , 35 , 36 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 49 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 ]. In addition, a few studies isolated the proteins in a combined solid phase extraction (SPE) [ 21 , 59 ] manner.…”

“…Based on vancomycin polarity and molecular weight size, vancomycin is most often separated using the reversed-phase liquid chromatography mode [ 21 , 22 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 59 , 60 , 61 , 62 , 63 , 65 ], and a few studies have used hydrophilic interaction chromatography [ 57 , 58 ] and reverse ion exchange chromatography [ 64 ]. The difference between the various separation modes lies in the choice of stationary and mobile phases.…”

“…The most commonly applied stationary phase in the reversed-phase liquid chromatography mode was a C 18 column [ 22 , 34 , 35 , 37 , 38 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 60 , 61 , 62 , 63 , 65 ], and a few used the C 8 column [ 21 , 36 , 50 , 59 ] and aminopropyl silica column [ 39 ]. In reversed-phase liquid chromatography mode, the most commonly used mobile phases for UV detection were acetonitrile and pH 2.5 buffer such as phosphate buffer [ 34 , 35 , 37 , 38 , 39 , 40 , 41 , 44 , 49 , 50 ], while MS detection was performed with acetonitrile and 0.1% formic acid [ 51 , 52 , 53 , 54 , 55 , 56 , …”