Development and validation of a reversed-phase HPLC method for the simultaneous analysis of simvastatin and tocotrienols in combined dosage forms.
ABSTRACT A RP-HPLC method for the simultaneous analysis of tocotrienol isoforms (TRF) and simvastatin (SIM) in SIM-TRF nanoparticles (NPs) was developed. Analytes were monitored by UV detection at 238 and 295 nm for SIM and TRF, respectively, using a gradient methanol/water elution. Calibration curves for TRF and SIM were linear over concentration range of 20-80 microg/mL and 1-10 microg/mL with correlation coefficients 0.9990 and 0.9991, respectively. The recovery of TRF and SIM from the NPs was in the range from 97.35 to 102.19% and from 92.71 to 104.35%, respectively. This developed method was successfully employed in quantifying both drugs in NPs for future use in cancer therapy.
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ABSTRACT: Simvastatin, is a lipid regulating drug, which is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coen-zyme A reductase (HMG-CoA reductase), obtained by synthesis from lovastatin. It is indicated in the treatment of hyper-lipidemias, including hypercholesterolaemias, combined mixed hyperlipidemia hyperlipoproteinemias, hypertriglyceride-mia, and primary dysbetalipoproteinemia. This review describes a brief overview of the chemistry including impurities and different synthetic schemes, pharmacokinetic, pharmacodynamic and adverse effect of simvastatin as well as the re-cent trends in drug–drug interaction studies of simvastatin with various drug categories such as antibacterials, anticoagu-lants, antidepressants, antifungals, antivirals, calcium-channel blockers, immunosuppressants, lipid regulating drugs and grapefruit juice. This review also focuses distinctly on comprehensive update of various analytical methods for the quanti-fication of simvastatin and/or its metabolites, impurities, degradants and other drugs.Current Pharmaceutical Analysis 01/2012; 8:135--156. · 1.33 Impact Factor
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ABSTRACT: Analytical validation is an essential component in allowing a laboratory to ensure routine acceptable performance of analytical methods. Despite the considerable amount of important published work on this subject, diversity still prevails in the employed methodologies because validation of an analytical method depends on the specific purpose of that method. This can lead to difficulties in validation approaches and the interpretation of results. Aiming to assist in the planning of validation methods, we discuss relevant approaches of various parameters in quantitative high-performance liquid chromatographic methods and validation fields in pharmaceutical analysis. Moreover, this article provides several up-to-date examples that should be useful as an introduction to analytical validation for practical applications in academic research or the industrial sector.Critical Reviews in Analytical Chemistry - CRIT REV ANAL CHEM. 01/2012; 42(1):87-100.
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