Abstract
Objective: A bioanalytical quantification method was developed for the simultaneous estimation of simvastatin (SIM) and ezetimibe (EZE) from the human plasma.
 Methods: The technique was developed and equipped with reverse-phase (RP) high-performance liquid chromatography, using RP-C18 column with an ultraviolet detector. For the estimation of SIM and EZE, the mobile phase (acetonitrile:acetate buffer pH 4.0, pH adjusted with acetic acid) was pumped at a flow rate of 0.8 ml/min in the ratio of 85:15% v/v and the eluents were monitored at 234 nm. A calibration graph to study linearity of the SIM and EZE in biological matrix was carried out in the concentration range of 400–4000 ng/ml for both these drugs SIM and EZE.
 Results: The developed method was validated according to the US FDA and European Medicines Agency guidelines for sensitivity, accuracy, precision, and stability. The obtained statistical data of validation were found to be within prescribed limit assures rigidity of the method. Both the drugs in combined form were estimated in human plasma by the proposed method.
 Conclusions: The developed method is free from solid-phase extraction so it becomes simple and economical. The method is efficient for precise and accurate quantification of SIM and EZE in plasma and hence applied for bioequivalence, bioavailability study in real clinical samples.
Highlights
Simvastatin (SIM) chemically 2-2-dimethylbutanoic acid, 1,2,3,7,8, 8a-hexahydro,3,7-dimethyl-8-[2(tetrahydro-4 hydroxy-6-oxo-2 pyran2-yl) ethyl]-1-naphthalenyl ester is an analog of lovastatin, in liver undergoes extensive metabolism to several open ring hydroxyl acids including the active ß-hydroxy acids
Bioanalytical method development and validation The objective of the validation of bioanalytical assay is to demonstrate that it is suitable for its intended purpose
The response of plasma was considerable as stated in guidelines. Both the drugs were estimated from the plasma, and any interference of the plasma and matrix effect was not observed during the development of simple isocratic RP-HPLC bioanalytical method with UV detection
Summary
Simvastatin (SIM) chemically 2-2-dimethylbutanoic acid, 1,2,3,7,8, 8a-hexahydro,3,7-dimethyl-8-[2(tetrahydro-4 hydroxy-6-oxo-2 pyran2-yl) ethyl]-1-naphthalenyl ester is an analog of lovastatin, in liver undergoes extensive metabolism to several open ring hydroxyl acids including the active ß-hydroxy acids. They are highly bound to plasma proteins [1,2,3,4]. The ß-lactam binds to the Niemann-Pick C1-like 1 protein on the gastrointestinal tract that is responsible for cholesterol absorption It may be used alone, it is marketed as a combination product with SIM [1,2,3]
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