A simple and validated HPLC method for vancomycin assay in plasma samples: the necessity of TDM center development in Southern Iran

Abstract

Background and purpose: Vancomycin is a glycopeptide antibiotic which is the drug of choice against methicillin-resistant Staphylococcus aureus . It has a narrow therapeutic index, and thus therapeutic drug monitoring (TDM), and clinical pharmacokinetic assessment are necessary in order to prevent adverse drug reactions such as nephrotoxicity. In this study, we aimed to develop a simple and validated HPLC method for vancomycin assay in order to establish a TDM center for patients admitted to the ICU of Nemazee Hospital in southern Iran. Experimental approach: In this study, a brief review of different parameters and variables which could affect the sensitivity, selectivity of the validated HPLC method for vancomycin determination were considered. According to the previous studies a simple, fast, and the relatively low-cost method was established for vancomycin determination in plasma samples. Findings/Results: The developed HPLC assay indicated a calibration curve with R-square of > 0.999, acceptable selectivity, the accuracy of 90-105%, CV% of less than 15%, the limit of quantification of 1 μg/mL, and limit of detection of 300 ng/mL. Vancomycin trough level, the area under the curve, renal clearance, the volume of distribution, and elimination constant were measured in patients using this validated method. Conclusion and implications: Validated method for assay of vancomycin plasma levels was used to quantify vancomycin levels of four patients who were admitted to the ICU of Nemazee Hospital. According to the results, two of these patients showed lower levels than recommended therapeutic purposes while one of them showed a toxic level. According to the results, the TDM assessment of vancomycin is strongly recommended for patients who are hospitalized in ICU.

Pharmacokinetic assessment of vancomycin in critically ill patients and nephrotoxicity prediction using individualized pharmacokinetic parameters

“…Blood samples were collected from these critically ill patients just before the fifth dose administration (trough 1), after the end of 1-h infusion of the fifth dose (peak), 6 h after the fifth dose administration (intermediate), and 12 h after the fifth dose or just before the sixth dose administration (trough 2). AUCτ was calculated in each patient using the trapezoidal method as described in our previous study ( Ghasemiyeh et al, 2020 ).…”

“…After that, the sample was mixed with 1,000 µL of methanol to precipitate plasma proteins and extract vancomycin from plasma samples. Finally, the mixture was centrifuged at 12,000 rpm for 15 min, and the supernatant was analyzed through a validated HPLC method described in detail before ( Usman et al, 2016 ; Ghasemiyeh et al, 2020 ). In this regard, the HPLC (Azura, Knauer, Germany) and C18 column (250 mm length × 4.6 mm I.D.…”

Preparation of Vancomycin-Loaded Aerogels Implementing Inkjet Printing and Superhydrophobic Surfaces

“…HPLC method conditions were set at 25 °C, a mobile phase of phosphate buffer (30 mM, pH 2.2) and acetonitrile (86:14% v/v ) operating at an isocratic flow of 0.72 mL/min for 7 min. Chromatograms were obtained at the wavelength of 205 nm [ 49 ]. Previously, a calibration curve of vancomycin was obtained and validated in the 0.5–50 μg/mL range (R 2 > 0.999) [ 50 ].…”

Risk Scoring System for Vancomycin-Associated Acute Kidney Injury

“…To achieve optimal efficacy and avoid nephrotoxicity of this drug, therapeutic drug monitoring (TDM) is recommended ( Rybak et al, 2020 ). VCM-associated nephrotoxicity such as acute kidney injury (AKI) is thought to be related to the serum trough level of the drug and/or the area under the curve (AUC) measured in the first 24 h of VCM use (AUC0-24 h) ( Bosso et al, 2011 ; van Hal et al, 2013 ; Finch et al, 2017 ; Ghasemiyeh et al, 2020 ; Poston-Blahnik and Moenster, 2021 ). Furthermore, concomitant use of nephrotoxic agents along with VCM has been reported to increase the risk of nephrotoxicity of the VCM ( Rutter et al, 2017 ; Gyamlani et al, 2019 ; Qin et al, 2020 ).…”