Simultaneous quantification of abemaciclib and letrozole in rat plasma: method development, validation and pharmacokinetic application
Abstract
Treatment through a combination of drugs involving cyclin D‐dependent kinase inhibitors like abemaciclib and aromatase inhibitor like letrozole proved to be a potential therapeutic regimen and first‐line treatment in estrogen receptor‐positive breast cancer. In this study, we developed a simple and simultaneous RP‐HPLC bioanalytical method for quantifying abemaciclib and letrozole in rat plasma. Abemaciclib and letrozole were separated on Zorbax Eclipse C 18 column employing a gradient elution method comprising 10 mM ammonium acetate (pH 5) and acetonitrile as mobile phase. The method was found to have acceptable selectivity, accuracy (97.20–118.17%), precision (1.10–9.39%) and stability in the validation experiment performed as per the US Food and Drug Administration guidelines. The method sensitivity was low at a concentration level of 100 ng/ml. The applicability of the method has been verified through a single‐dose oral pharmacokinetic study in rat. The developed method will be useful to quantitate the analytes in rat plasma samples of different preclinical studies including their pharmacokinetic drug–drug interactions in the future. To date, no method has been reported for the quantification of abemaciclib and letrozole simultaneously in any type of biological matrices. Therefore, this study makes a definite significant contribution in the field of bioanalytical research.
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These PK results are in close agreement with previously reported results for oral administration of LTZ.
“These results are in close agreement with the results reported previously for oral administration of LTZ (Wempe et al. 2007; Dhakne et al. 2020).”
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 Dhakne et al. 2020
The sensitivity of the present method is considerably more than previous reports where LLOQ was observed at 0.15 μg/mL and 0.1 μg/mL.
“The sensitivity of the present method is considerably more compared to previous reports where LLOQ was observed at 0.15 μ g/mL and 0.1 μ g/mL (Acharjya et al. 2012; Dhakne et al. 2020).”
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 Dhakne et al. 2020
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Effects of estrogen on breast cancer development: Role of estrogen receptor independent mechanisms
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Morschhauser, F., Bouabdallah, K., Stilgenbauer, S., Thieblemont, C., Wolf, M., de Guibert, S., Zettl, F., Hahka-Kemppinen, M., Xiaohui Wang, D., Brueck, P., et al. (2014) · Blood · doi:10.1182/blood.v124.21.3067.3067 · Cited by 20 · see citing works
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Shawky, A. M., & El-Tohamy, M. F. (2021) · Polymers · doi:10.3390/polym13091384 · Cited by 34 · see citing works
“LTZ was previously quantified using various analytical techniques, including chromatographic separation such as high-performance thin layer chromatography [26], reversed phase liquid chromatography [27,28], liquid chromatography coupled with tandem mass spectrometry [29,30], and capillary zone electrophoresis [31].”
MethodHegde, 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
“The sensitivity of the present method is considerably more compared to previous reports where LLOQ was observed at 0.15 μg/mL and 0.1 μg/mL (Acharjya et al. 2012; Dhakne et al. 2020).”
MethodResultInfluential
- Authors
- Dhakne, P., Sahu, A. K., Sharma, M. K., & Sengupta, P.
- Affiliations
- National Institute of Pharmaceutical Education and Research - Ahmedabad (IN)
- Corresponding author
- Sengupta, Pinaki
- Venue
- Biomedical Chromatography
- Publisher
- Wiley
- Published
- 2020-03-31
- Volume
- 34
- Issue
- 6
- Pages
- e4825-e4825
- ISSN
- 0269-3879 (ISSN-L)
- 1099-0801
- OpenAlex
- W3010879084
- Cited by
- 16
- References
- 2
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 2 · 2023: 2 · 2022: 5 · 2021: 4 · 2020: 1
- FWCI
- 1.56
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Biomedical Chromatography (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Forensic Toxicology and Drug Analysis
- Keywords
- abemaciclib, letrozole, simultaneous determination, rat plasma, pharmacokinetics, aromatase inhibitors, estrogen receptor-positive breast cancer, drug-drug interactions, bioanalytical method validation, reversed-phase HPLC
- MeSH terms
- Letrozole, Aminopyridines, Animals, Benzimidazoles, Chromatography, High Pressure Liquid, Female, Reproducibility of Results, Linear Models, Rats, Sprague-Dawley, Rats, Limit of Detection
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