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A Validated Method for Quantification of Dolutegravir Using Ultra Performance Liquid Chromatography Coupled With UV
Xinzhu Wang1, Sujan Dilly Penchala, Alieu Amara
1*Jefferiss Trust Laboratories, Faculty of Medicine, Imperial College London, St Mary's Hospital Campus; †Department of Molecular and Clinical Pharmacology, University of Liverpool; and ‡St Stephen's Centre, Chelsea and Westminster Foundation Trust, London, United Kingdom.
A new analytical method accurately quantifies dolutegravir (DTG) in plasma, crucial for HIV treatment. This validated assay is simple, robust, and cost-effective for clinical use.
Area of Science:
- Analytical Chemistry
- Pharmacology
- Biochemistry
Background:
- Dolutegravir (DTG) is an integrase strand transfer inhibitor used for HIV treatment.
- Pharmacological aspects of DTG require further investigation.
- A validated analytical method for DTG quantification in plasma is needed.
Purpose of the Study:
- To develop and validate a robust analytical method for quantifying DTG in human plasma.
- To establish a reliable assay for pharmacokinetic and therapeutic drug monitoring.
Main Methods:
- Protein precipitation for plasma sample extraction (100 µL).
- C8 reverse-phase HPLC with gradient elution (formic acid/ammonium acetate and acetonitrile).
- UV detection at 258 nm with a 10-minute run time.
Main Results:
- Linearity validated over 0.25-10 mcg/mL (r > 0.9999).
- High precision (intra-assay: 3.3–6.1%, inter-assay: 4.5–5.7%) and accuracy (90.7–97.7%).
- Extraction recovery (94.3–100%) and selectivity confirmed, with no interferences.
Conclusions:
- The developed method is simple, robust, selective, accurate, precise, and cost-effective.
- The assay is suitable for clinical settings, pharmacokinetic studies, and therapeutic drug monitoring.
