SPE–UPLC–MS/MS assay for determination of letrozole in human plasma and its application to bioequivalence study in healthy postmenopausal Indian women
Open accessAbstract
A rapid and sensitive ultra performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) method is described for determination of letrozole in human plasma. Following solid phase extraction (SPE) of letrozole and letrozole-d4 on Orochem DVB-LP cartridges, chromatography was performed on Acquity UPLC BEH C 18 (50 mm×2.1 mm, 1.7 µm) column using methanol-0.1% formic acid in water (85:15, v/v) as the mobile phase. Detection was carried out on a triple quadrupole mass spectrometer with an electrospray source, operated under positive ionization mode. Quantitation of letrozole and letrozole-d4 was done using multiple reaction monitoring (MRM) following the transitions at m/z 286.2→217.0 and m/z 290.2→221.0, respectively. The calibration plots were linear through the concentration range of 0.10–100 ng/mL ( r 2 ≥0.9990) using 100 µL human plasma. The extraction recovery of letrozole ranged from 94.3% to 96.2% and the intra-batch and inter-batch precision was ≤5.2%. The method was successfully applied to a bioequivalence study of letrozole after oral administration of 2.5 mg tablet formulation to 16 healthy postmenopausal Indian women. The assay reproducibility was also established through incurred sample reanalysis (ISR) of 74 subject samples.
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LC-MS-MS methods for LTZ in plasma are sensitive and selective with low level of quantification but require trained personnel and sophisticated equipment.
“The liquid chromatographic method utilizing MS-MS systems has been used for the analysis of LTZ letrozole in plasma, which are sensitive and selective with a low level of quantification. However, such methods require operation by trained personnel and sophisticated equipment (Joshi et al. 2011; AlShehri et al. 2019; Vanol et al. 2016).”
From A simple, precise, and sensitive HPLC method for quantification of letrozole in rat plasma: development, validation, and preclinical pharmacokinetics (2021) · cites this paper as Vanol et al. 2016
The Introduction and Conclusion describe LC–MS/MS methods for letrozole in human plasma as sensitive and selective, with low quantification limits; the Experimental section documents the specialized UPLC and mass-spectrometry equipment used. Our copy does not state that these methods require trained personnel. (LLM, conf=0.87)
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Research works printed but not linked: 10
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- [15]Beer B. Schubert B. Oberguggenberger A. Development and validation of a liquid chromatography–tandem mass spectrometry method for the simultaneous quantification of tamoxifen, anastrozole, and letrozole in human plasma and its application to a clinical study Anal. Bioanal. Chem. 398 2010 1791 1800 20730580
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Hegde, A. R., Padya, B. S., Soman, S., & Mutalik, S. (2021) · Journal of Analytical Science and Technology · doi:10.1186/s40543-021-00276-4 · Cited by 17 · see citing works
“However, such methods require operation by trained personnel and sophisticated equipment (Joshi et al. 2011; AlShehri et al. 2019; Vanol et al. 2016).”
Background
- Authors
- Vanol, P. G., Singhal, P., Shah, P. A., Shah, J. V., Shrivastav, P. S., & Sanyal, M.
- Affiliations
- St Xavier’s College (IN)
- Alkem (India) (IN)
- Gujarat University (IN)
- Corresponding author
- Sanyal, Mallika
- Venue
- Journal of Pharmaceutical Analysis
- Publisher
- Elsevier BV
- Published
- 2016-08
- Volume
- 6
- Issue
- 4
- Pages
- 276-281
- ISSN
- 2095-1779 (ISSN-L)
- PMC
- PMC5762604
- OpenAlex
- W2397876743
- Cited by
- 22
- References
- 0
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 4 · 2023: 1 · 2022: 3 · 2021: 2 · 2020: 6 · 2019: 1 · 2018: 2 · 2017: 1
- FWCI
- 1.05
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal of Pharmaceutical Analysis (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Department of Chemistry, St. Xavier's College, Ahmedabad
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Life Sciences › Agricultural and Biological Sciences › Food Science › Pesticide Residue Analysis and Safety
- Keywords
- letrozole, bioequivalence, human plasma, solid-phase extraction, UPLC-MS/MS, postmenopausal women, oral tablet formulation, pharmaceutical analysis, isotope-labeled internal standards, incurred sample reanalysis
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