Method Development and Validation for Tenofovir an Antiretroviral Drug in Plasma by LC-MS/MS Technique
Öz
Bioanalytical method development for Tenofovir (TFR) as an antiretroviral drug by LCMS Technique. A developed Bioanalytical analysis method for TFR can be used routinely in a commercial laboratory. All the solvents used were of HPLC grade. 4000 QTrap along with the Shimadzu LC 20AD LC System used to develop and validate the method. The LLOQ and LOQ for Tenofovir was found were 5ng/mL and 15ng/mL. The method was accurate (within ±15% of control) and precise (coefficient of variation ≤15%). Analytes were stable for five freeze/thaw cycles and up to 6 days at room temperature, whereas long-term at −20°C or at −80°C. For Precision study using QCs of the drug- 85%, 100% and 115% concentration of drug chosen and the levels M1QC (75ng/mL), MQC (300ng/mL) and HQC (600ng/mL) where the % CV were observed of ≤ 15%. In a Precision and Accuracy study (inter day and intraday), the % CV obtained for Tenofovir was observed ≤ 15%. Recovery studies for extracted samples with LQC (15ng/mL), MQC (300ng/mL) and HQC (600ng/mL) were 94.51%, 91.83% and 90.91% respectively. Stability was within 15% deviation. The results of System Suitability Test for TFR and Acyclovir (ACR) are an internal standard with observed %CV ≤ 2.0%. The aim of the study was to develop a method that could be used as an alternative to the existing Tenofovir indirect method. The existing method observes separating the parent drug from the metabolite in LCMS/MS. This method is a good alternative to the indirect methods currently in use.
Anahtar Kelimeler
Kaynakça
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Öz
Kaynakça
- [1] A, Dhingra N, Kumar P, Sahu D, Reddy DC, Narayan P, Raj Y, Sangal B, Chandra N, Nair S, Singh J. Sustained progress, but no room for complacency: Results of 2015 HIV estimations in India. Indian J Med Res. 2017; 146(1): 83-96.
- [2] Nah K, Nishiura H, Tsuchiya N. Test-and-treat approach to HIV/AIDS: a primer for mathematical modeling. Theor Biol Med Model. 2017; 14(1): 1-11.
- [3] Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a2.htm (accessed on 13 Oct 2022).
- [4] VIREAD, https://www.rxlist.com/viread-drug.htm (accessed on 13 Oct 2022).
- [5] Donnell D, Baeten JM, Bumpus NN, Brantley J, Bangsberg DR, Haberer JE, Mujugira A, Mugo N, Ndase P, Hendrix C, Celum C. HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention. J Acq Immun Def Synd. 2014; 66(3): 340-348.
- [6] An ambitious treatment target to help end the AIDS epidemic. https://www.unaids.org/en/resources/documents/2017/90-90-90 (accessed on 13 Oct 2022).
- [7] Rani R, Medhe S, Srivastava M. HPTLC–MS based method development and validation for the detection of adulterants in spices. J Food Meas Charact. 2015; 9(2): 186-194.
- [8] Yadav M, Singhal P, Goswami S, Pande UC, Sanyal M, Shrivastav PS. Selective determination of antiretroviral agents tenofovir, Emtricitabine, and lamivudine in human plasma by a LC-MS-MS method for a bioequivalence study in healthy Indian subjects. J Chromatogra Sci. 2010; 48(9): 704-13.
- [9] Delahunty T, Bushman L, Fletcher CV. Sensitive assay for determining plasma tenofovir concentrations by LC/MS/MS. J Chromatogr B. 2006; 830(1): 6-12.
- [10] Gomes NA, Vaidya VV, Pudage A, Joshi SS, Parekh SA. Liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for simultaneous determination of tenofovir and Emtricitabine in human plasma and its application to a bioequivalence study. J Pharmaceut Biomed. 2008; 48(3): 918-26.
- [11] Kim DH, Cho JY, Chae SI, Kang BK, An TG, Shim WS, Noh YS, Hwang SJ, Chung EK, Lee KT. Development of a simple and sensitive HPLC-MS/MS method for determination of diazepam in human plasma and its application to a bioequivalence study. Transl Clin Pharmacol. 2017; 25(4): 173-178.
- [12] Takahashi M, Kudaka Y, Okumura N, Hirano A, Banno K, Kaneda T. Determination of plasma tenofovir concentrations using a conventional LC-MS method. Biol Pharm Bull. 2007; 30(9): 1784-1786.
- [13] Bioanalytical Method Validation Guidance for Industry May 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry (accessed on 13 Oct 2022).
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Eczacılık ve İlaç Bilimleri (Diğer) |
| Bölüm | Articles |
| Yazarlar | |
| Yayımlanma Tarihi | 28 Haziran 2025 |
| Yayımlandığı Sayı | Yıl 2023 Cilt: 27 Sayı: 5 |