Why the study?
Does a test formulation of amlodipine/olmesartan 10/40 mg demonstrate bioequivalence to a reference formulation in healthy volunteers?
Does a test formulation of amlodipine/olmesartan 10/40 mg demonstrate bioequivalence to a reference formulation in healthy volunteers?
A newly developed LC-MS/MS method successfully demonstrated bioequivalence between two formulations of amlodipine/olmesartan 10/40 mg in healthy volunteers.
Answers are grounded in this paper and cite their sources.
May support substitution with the test formulation; confirms bioequivalence for amlodipine/olmesartan 10/40 mg.
The present study describes a sensitive, specific and rapid method based on liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) for the simultaneous determination of amlodipine (AML) and olmesartan (OLM) in human plasma by using amlodipine D4 (IS1) and olmesartan D6 (IS2) as internal standards. Plasma samples were extracted by solid-phase extraction (SPE). The method was validated over parameters like selectivity, matrix effect, sensitivity, specificity, linearity, precision and accuracy, various stabilities in plasma, recovery and reinjection reproducibility. During the validation, inter and intra-batch precision were less than 15% and the accuracy was within 85-115%. Extraction recoveries were 75.30%, 81.41%, 79.19% and 81.72% for AML, OLM, IS1 and IS2 respectively. The method was applied to the pharmacokinetic study of OLM and AML in healthy subjects following a single oral dose of OLM and AML 40 mg/10 mg.
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Jain et al. (2016) studied this question.
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