Determination of nifedipine in human plasma by solid-phase extraction and high-performance liquid chromatography: validation and application to pharmacokinetic studies

Niopas, Ioannis; Daftsios, Athanasios C.

doi:10.1016/s0731-7085(03)00162-6

Cited by 39 publications

(27 citation statements)

References 25 publications

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“…These included theophylline [7], ranitidine hydrochloride [9] (reported in articles concerning the HPLC-UV determination of ezetimibe), metformin hydrochloride [17], fenofibrate [18] and nitrendipine [19] (for which the reported analytical wavelengths were close to the one used in our investigation). For all the substances tested, 1 μg mL −1 methanolic solutions were prepared.…”

Section: Internal Standardmentioning

confidence: 59%

RP-HPLC-UV Determination of ezetimibe in serum: Method development, validation and application to patients chronically receiving the drug

Suchy¹,

Łabuzek²,

Pierzchała³

2013

Acta Chromatographica

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Summary.Ezetimibe is the first in a new class of antihypercholesterolemic drugs. Since it has not long been available on the market, many of its properties may still be revealed. Analytical methods for its determination are scarce, especially regarding serum samples. A simple, fast, and effective high-performance liquid chromatography-ultraviolet (HPLC-UV) method for the determination of ezetimibe concentration in human serum has therefore been developed. Three mobile phases were analysed, and original modifications to the concentration and flow parameters were made. Of five potential internal standards (IS), only nitrendipine was found to be suitable. The analytical wavelength was chosen based on the absorption spectrum of ezetimibe in the mobile phase. Finally, an extraction analysis was performed using two different solvents, and the extrahent volume was optimised. The final method developed was as follows. Single extraction of 1 mL serum sample, spiked with IS, was performed using 10 mL of methyl-t-butyl ether. Separation was obtained at ambient temperature on a Waters C18 Symmetry Shield (4.6 mm × 250 mm, 5 μm) column. The isocratic mobile phase was composed of acetonitrile and 0.1 M ammonium acetate aqueous solution 55:45 (v/v), set at flow rate of 0.75 mL min −1 . Ezetimibe was detected at a wavelength of 232 nm after 5.49 min, and the IS was detected at 8.05 min. The developed method has been validated according to ICH standards. It was found to be specific, precise, accurate and linear over the range 10-800 ng mL −1 with R 2 > 0.998, and detection and quantification limits of 4.60 ng mL −1 and 13.94 ng mL −1 , respectively. The method has been applied to clinical serum samples. The developed technique allowed for successful in vivo assessment of ezetimibe concentrations in samples obtained from hypercholesterolemia patients who are chronically receiving the drug.

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Section: Internal Standardmentioning

confidence: 59%

RP-HPLC-UV Determination of ezetimibe in serum: Method development, validation and application to patients chronically receiving the drug

Suchy¹,

Łabuzek²,

Pierzchała³

2013

Acta Chromatographica

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“…After that, molecular imprinting technique has undergone rapid development in 1990s. Because of the advantages over biopolymers, such as low cost, good physical and chemical stability and tailor-made selectivity for a target molecule, the MIPs materials have been widely applied in solid-phase extraction [16][17][18]. Given that nifedipine is a highly unstable compound, which is rapidly photo-degraded to its nitroso analogue when exposed to daylight [19] and its plasma protein binding rate reached 98%, on line solid-phase extraction is suitable for the pretreatment of plasma sample instead of liquid-liquid extraction and traditional off-line SPE.…”

Section: Introductionmentioning

confidence: 99%

Preparation of a Novel Emulsion-Templated MIP Monolith and its Application for on Line Assay of Nifedipine in Human Plasma

Yang¹,

Liu²,

Liu³

et al. 2010

J Chromatograph Separat Techniq

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“…These include high performance thin layer chromatography, 4 high performance liquid chromatography, 5 gas chromatography coupled with mass spectrometry, 6 micellar electrokinetic chromatography, 7 flow injection analysis, 8 electroanalytical methods 9 and UV spectrophotometry. 10 The estimation of nifedipine in single and combined dosage forms has been made using second order 11 and first order 12 derivative spectra, respectively.…”

Section: Introductionmentioning

confidence: 99%

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Rahman¹,

Azmi²

2006

ScienceAsia

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A validated spectrophotometric method has been described for the assay of nifedipine in bulk and commercial dosage forms. The method is based on the oxidation of drug with Fe(III) at pH 1.42. The reduced Fe(II) subsequently reacts with 1,10-phenanthroline to produce a red colored tris(1,10-phenanthroline) iron(II) complex, which absorbs maximally at 505 nm. Beer's law is obeyed in the concentration range 0.5 -14.0 µg mL -1 with molar absorptivity and Sandell' s sensitivity of 2.805×10 4 L mol -1 cm -1 and 0.012 µg cm -2 per 0.001 absorbance unit, respectively. The various experimental parameters were optimized. The method has been successfully applied for the quantitation of the drug in commercial dosage forms. The results of analysis were statistically compared with those of a reference method showing acceptable recovery and precision. The experimental true bias of all samples based on recovery experiments were within ± 2 %.

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Determination of nifedipine in human plasma by solid-phase extraction and high-performance liquid chromatography: validation and application to pharmacokinetic studies

Cited by 39 publications

References 25 publications

RP-HPLC-UV Determination of ezetimibe in serum: Method development, validation and application to patients chronically receiving the drug

RP-HPLC-UV Determination of ezetimibe in serum: Method development, validation and application to patients chronically receiving the drug

Preparation of a Novel Emulsion-Templated MIP Monolith and its Application for on Line Assay of Nifedipine in Human Plasma

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