A New Approach for Dealing with the Stability of Drugs in Biological Fluids

Timm, U.; Wall, Michael; Dell, D.

doi:10.1002/jps.2600740913

Cited by 99 publications

(36 citation statements)

References 11 publications

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“…Degradation of fleroxacin, exposed to sunlight, was prevented by covering samples with aluminum foil. We observed fleroxacin degradation up to 15% in plasma samples placed in a sunny position at 22°C over 24 h. Degradation was seen on chromatograms by new peaks (retention times different from those of metabolites) getting higher with time of exposure (14). Plasma samples were stored at -80°C until analyzed.…”

mentioning

confidence: 99%

Pharmacokinetics and tissue penetration of fleroxacin after single and multiple 400- and 800-mg-dosage regimens

Panneton

Bergeron

LeBel

1988

Antimicrob Agents Chemother

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The pharmacokinetics and suction-induced blister fluid penetration of fleroxacin following single and multiple (every 24 h for 5 days) oral administration of 400- and 800-mg-dosage regimens were studied in 12 young male volunteers. Plasma and urine samples up to 72 h were assayed by high-pressure liquid chromatography. The peak levels of fleroxacin in plasma were significantly higher after multiple dosing of 800 mg (14.3 versus 8.2 micrograms/ml; P less than 0.01) but not after the last 400-mg dose (6.7 versus 5.0 micrograms/ml). Increased elimination half-life occurred after multiple dosing of 800 mg, from 13.45 +/- 2.94 to 15.60 +/- 3.16 h (P less than 0.05). Mean peak concentrations in blister fluid were significantly different when the first (3.7 +/- 0.8 and 7.7 +/- 1.8 micrograms/ml for 400 and 800 mg, respectively) and last (5.7 +/- 0.9 and 12.3 +/- 2.1 micrograms/ml for 400 and 800 mg, respectively) doses were compared (P less than 0.01). The percentage of blister fluid (BF) penetration (AUCBF/AUCplasma, where AUC is area under the concentration-time curve) yielded values greater than 100% (range, 113.7 to 132.6%). After multiple administration of 800 mg, fleroxacin was cleared from the body more slowly: from 98.80 ml/min after a single dose to 77.72 ml/min following 800 mg every 24 h (P less than 0.01). Saturation of apparent nonrenal clearance is suggested to explain this difference. Fleroxacin was well tolerated by the volunteers.

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mentioning

confidence: 99%

Pharmacokinetics and tissue penetration of fleroxacin after single and multiple 400- and 800-mg-dosage regimens

Panneton

Bergeron

LeBel

1988

Antimicrob Agents Chemother

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“…25 In contrast to Ro 48-3656 and Ro 44-3888, Ro 48-3657 was found to be unstable in human plasma at room temperature for periods longer than 0.5 h if no esterase inhibitor was used (Table 6). Decreases in concentration of 18% and 8.9% were found following storage of a 10 ng ml~1 plasma sample at ambient temperature (22 ¡C) for 1 h and at [20 ¡C for 48 h, respectively.…”

Section: Stability In Plasma and Precipitation Mediummentioning

confidence: 92%

Column-switching High-performance Liquid Chromatography Combined with Ionspray Tandem Mass Spectrometry for the Simultaneous Determination of the Platelet Inhibitor Ro 44-3888 and its Pro-drug and Precursor Metabolite in Plasma

1997

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“…Stability data are obtained from two or three different concentration levels (low, medium and high concentrations of the linearity range) at different time intervals after storing, performing replicate analysis (between 5 and 10 experiments) [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][77][78][79][80][81][82][83][84][85][86][87][88]. For the determination of compound amount, freshly prepared calibration samples must be diluted from stock solutions using the same substance batch, same blank in the matrix of pharmaceutical dosage forms and same blank biological matrix as used for the stored samples [77][78][79][80][81][82][83][84][85][86][87][88]. A few hours of standard and sample solution stability can be required even for fast voltammetric methods [1][2]...…”

Section: Stabilitymentioning

confidence: 99%

“…For the determination of compound amount, freshly prepared calibration samples must be diluted from stock solutions using the same substance batch, same blank in the matrix of pharmaceutical dosage forms and same blank biological matrix as used for the stored samples [77][78][79][80][81][82][83][84][85][86][87][88]. A few hours of standard and sample solution stability can be required even for fast voltammetric methods [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][77][78][79][80][81][82][83][84][85][86][87][88][89][90][91]. A t-test can be applied to assess analyte stability.…”

Section: Stabilitymentioning

confidence: 99%

The Role of and the Place of Method Validation in Drug Analysis Using Electroanalytical Techniques

Gümüştaş¹,

Özkan²

2014

TOACJ

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Electroanalytical methods are chosen for the sensitive analysis of pharmaceutically active compounds in their dosage forms and biological samples. Electroanalytical method validation is the process used to confirm that the determination procedure employed for a specific test is suitable for its intended use like other analytical methods. Results from electroanalytical method validation can be used to judge the quality, applicability, accuracy, reliability and consistency of analytical results; it is an integral part of any analytical procedure. Also in electroanalytical drug analysis, important decisions are taken which are based on data obtained from real samples. Validation parameters help assure that the electroanalytical methods ensure the correct identity, strength, quality, accurate, precise, selective, robust and sensitive. A well-defined and well-documented validation process provides regulatory agencies with evidence that the system and method suitable for its intended use. Method validation is an essential component of the measures that a laboratory should implement to permit it to produce reliable electroanalytical data.

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A New Approach for Dealing with the Stability of Drugs in Biological Fluids

Cited by 99 publications

References 11 publications

Pharmacokinetics and tissue penetration of fleroxacin after single and multiple 400- and 800-mg-dosage regimens

Pharmacokinetics and tissue penetration of fleroxacin after single and multiple 400- and 800-mg-dosage regimens

Column-switching High-performance Liquid Chromatography Combined with Ionspray Tandem Mass Spectrometry for the Simultaneous Determination of the Platelet Inhibitor Ro 44-3888 and its Pro-drug and Precursor Metabolite in Plasma

The Role of and the Place of Method Validation in Drug Analysis Using Electroanalytical Techniques

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