ArticleDrug design, development and therapy2026
An LC-MS/MS Method for Simultaneous Determination of Almonertinib and Atorvastatin: Evaluating Their Drug-Drug Interactions in Rat.
Article in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: Atorvastatin is frequently used in combination with almonertinib in lung cancer patients who present with comorbid dyslipidemia. Both drugs are metabolized by CYP3A4, potentially leading to drug-drug interactions (DDIs) that increase the risk of adverse reactions. This study aimed to develop a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantifying almonertinib and atorvastatin and evaluate the DDIs between these two drugs in rats. Methods: An LC-MS/MS method was developed to determine almonertinib and atorvastatin in rat plasma and was fully validated in accordance with the ICH M10 bioanalytical method validation guideline and Chinese Pharmacopoeia 2020 Edition. Rats were divided into 5 groups (n=7 per group), and received the following treatments: almonertinib alone, atorvastatin alone, almonertinib combined with atorvastatin, vehicle control, or almonertinib after a long-term regimen of atorvastatin. The plasma samples were collected from each rat and analyzed using this method. The pharmacokinetic parameters were calculated and the DDIs were evaluated. Results: An LC-MS/MS method was established and validated according to the requirements. Animal studies revealed that co-administration of almonertinib with atorvastatin significantly increased C Conclusion: The study successfully established an LC-MS/MS method for simultaneous determination of almonertinib and atorvastatin and assessed the DDIs of these two drugs in rat. Animal experiment demonstrated significant DDIs between two drugs no matter single dose or multiple doses were administered, which obviously increased the drug exposure and inhibited elimination. Close attention should be paid to the combination regimens of these two drugs in clinical practice.
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