Related Experiment Video
Updated: Jan 1, 2026
An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin
Maciej Stawny1, Aleksandra Gostyńska1, Katarzyna Dettlaff1
1Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, 6 Grunwaldzka, 60-780 Poznań, Poland.
Background:
The administration of total parenteral nutrition (TPN) is a common procedure in intensive care units, where the concomitant use of other intravenous medication is frequently needed. One of the particularly dangerous complications for neurosurgical patients is meningitis, for which high doses of ampicillin (AMP) are used. In such cases, the addition of AMP to TPN admixtures would be a desirable procedure. Thus, the AMP determination method in TPN admixture was developed and validated.
Methods:
An isocratic HPLC analysis was performed on a LiChrospher C18 end-capped column (250 mm, 4.6 mm, 5 µm) with a C18 pre-column (LiChrospher 100, 4 mm, 5 µm). The flow rate was 1.0 mL min-1 and the detection wavelength was 230 nm. System suitability parameters, such as capacity factor, numbers of the theoretical plate, asymmetry factor, as well as validation parameters, including method precision, accuracy, linearity, selectivity, and robustness, were set up.
Results:
The method was shown to be linear, precise, accurate, specific, and robust, and it can be used for the quantitative analysis of AMP in TPN admixtures.
Conclusions:
The degradation of AMP in the TPN admixtures occurred according to first order kinetics. The degradation rate was high and dependent on the composition of the mixture and the storage conditions (t0.5 varied from 142.44 h to 300.45 h).
Insights
A new HPLC method accurately quantifies ampicillin (AMP) in total parenteral nutrition (TPN) admixtures. This method is crucial for neurosurgical patients, but AMP degrades rapidly in TPN, necessitating careful administration and monitoring.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
- Clinical Pharmacy
Background:
- Total parenteral nutrition (TPN) is frequently administered in intensive care units.
- Neurosurgical patients often require high-dose ampicillin (AMP) for meningitis treatment.
- Combining AMP with TPN admixtures is desirable but requires a validated determination method.
Purpose of the Study:
- To develop and validate a method for determining ampicillin (AMP) concentrations in total parenteral nutrition (TPN) admixtures.
- To assess the stability and degradation kinetics of AMP within TPN solutions.
Main Methods:
- Isocratic High-Performance Liquid Chromatography (HPLC) using a LiChrospher C18 column.
- Analysis included system suitability and validation parameters: precision, accuracy, linearity, selectivity, and robustness.
- Detection was performed at 230 nm with a flow rate of 1.0 mL/min.
Main Results:
- The developed HPLC method demonstrated linearity, precision, accuracy, specificity, and robustness.
- The method is suitable for the quantitative analysis of AMP in TPN admixtures.
- Ampicillin degradation in TPN admixtures followed first-order kinetics.
Conclusions:
- Ampicillin exhibits rapid degradation in TPN admixtures, with a half-life ranging from 142 to 300 hours.
- The degradation rate is influenced by TPN composition and storage conditions.
- The validated method enables accurate monitoring of AMP in TPN, crucial for patient safety.
Related Concept Videos
01:15Determination of Multiple Dosing Parameters: Steady-State, Minimum and Maximum Concentrations
01:25Determination of Multiple Dosing Parameters: Loading and Maintenance Doses
00:54Noncompartmental Analysis: Miscellaneous Pharmacokinetic Parameters
One key aspect of the noncompartmental approach is determining a drug's total clearance. This can be done by dividing the drug dose by the area under the concentration-time curve from zero to infinity. The area under the concentration-time curve represents the drug's...