Olagunju, Adeniyi 
ORCID: 0000-0002-6588-5749, Nwogu, Jacinta, Eniayewu, Oluwasegun, Atoyebi, Shakir ORCID: 0000-0002-1393-3753, Amara, Alieu, Kpamor, John, Bolaji, Oluseye, Adejuyigbe, Ebunoluwa, Owen, Andrew ORCID: 0000-0002-9819-7651 and Khoo, Saye ORCID: 0000-0002-2769-0967
(2021)
Validation and clinical application of a method to quantify efavirenz in cervicovaginal secretions from flocked swabs using liquid chromatography tandem mass spectrometry.
Wellcome Open Research, 6.
p. 246.
Abstract
<ns4:p><ns4:bold>Background</ns4:bold><ns4:bold>: </ns4:bold>A liquid chromatography tandem mass spectrometry method to quantify drugs in dried cervicovaginal secretions from flocked swabs was developed and validated using the antiretroviral efavirenz as an example.</ns4:p><ns4:p> <ns4:bold>Methods: </ns4:bold>Cervicovaginal swabs (CVS) were prepared by submerging flocked swabs in efavirenz-spiked matrix. Time to full saturation, weight uniformity, recovery and room temperature stability were evaluated. Chromatographic separation was on a reverse-phase C18 column by gradient elution using 1mM ammonium acetate in water/acetonitrile at 400 µL/min. Detection and quantification were on a TSQ Quantum Access triple quadrupole mass spectrometer operated in negative ionisation mode. The method was used to quantify efavirenz in CVS samples from human immunodeficiency virus (HIV)-positive women in the VADICT study (NCT03284645). A total of 98 samples (35 paired intensive CVS and DBS samples, 14 paired sparse CVS and DBS samples) from 19 participants were available for this analysis.</ns4:p><ns4:p> <ns4:bold>Results:</ns4:bold> Swabs were fully saturated within 15 seconds, absorbing 128 µL of matrix with coefficient of variation (%CV) below 1.3%. The method was linear with a weighting factor (1/X) in the range of 25-10000 ng/mL with inter- and intra-day precision (% CV) of 7.69-14.9%, and accuracy (% bias) of 99.1-105.3%. Mean recovery of efavirenz from CVS was 83.8% (%CV, 11.2) with no significant matrix effect. Efavirenz remained stable in swabs for at least 35 days after drying and storage at room temperature. Median (range) CVS efavirenz AUC<ns4:sub>0-24h</ns4:sub> was 16370 ng*h/mL (5803-22088), C<ns4:sub>max</ns4:sub> was 1618 ng/mL (610-2438) at a T<ns4:sub>max</ns4:sub> of 8.0 h (8.0-12), and C<ns4:sub>min</ns4:sub> was 399 ng/mL (110-981). Efavirenz CVS:plasma AUC<ns4:sub>0-24</ns4:sub> ratio was 0.41 (0.20-0.59).</ns4:p><ns4:p> <ns4:bold>Conclusions: </ns4:bold>Further application of this method will improve our understanding of the pharmacology of other therapeutics in the female genital tract, including in low- and middle-income countries.</ns4:p>
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | HIV/AIDS, 3 Good Health and Well Being |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 27 Sep 2021 07:17 |
| Last Modified: | 14 Mar 2024 17:54 |
| DOI: | 10.12688/wellcomeopenres.17202.1 |
| Open Access URL: | https://doi.org/10.12688/wellcomeopenres.17202.1 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3138257 |
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