Rapid determination of granisetron in human plasma by liquid chromatography coupled to tandem mass spectrometry and its application to bioequivalence study

Jiang, Yunyun; Fan, Guorong; Chen, Yi; Li, Zhen; Zhao, Wei; Wu, Yutian; Jin-hong, HU

doi:10.1016/j.jpba.2006.05.001

Cited by 26 publications

(12 citation statements)

References 14 publications

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“…Considering the fact that granisetron is a relatively hydrophilic compound with a logarithm of partition coefficient (log P ) of 1.88 (obtained from Chemicalize, http://www.chemicalize.org/structure/#!mol=granisetron&source=fp), various chromatographic columns, including Xselect HSS T3, Atlantis T3, Luna C 8 and Symmetry C 18 were compared with regard to the retention time, peak shape and sensitivity of granisetron during the chromatographic procedure. In previous publications (Jiang et al ., , Nirogi et al ., ), a standard C 18 column has been used for granisetron assay, although with very short retention (1 to 1.6 min). In the present study, a Symmetry C 18 column was initially tested; however, it exhibited poor retention for granisetron with a retention factor of 0 with various mobile phases.…”

Section: Resultsmentioning

confidence: 99%

Development and validation of a sensitive liquid chromatographic–tandem mass spectrometric method for the simultaneous analysis of granisetron and 7‐hydroxy granisetron in human plasma and urine samples: application in a clinical pharmacokinetic study in pregnant subject

Zhao

Chen

Caritis

et al. 2015

Biomedical Chromatography

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A liquid chromatography-tandem mass spectrometric method for the quantification of granisetron and its major metabolite, 7-hydroxy granisetron in human plasma and urine samples was developed and validated. Respective stable isotopically labeled granisetron and 7-hydroxy granisetron were used as internal standards (IS). Chromatography was performed using an Xselect HSS T3 analytical column with a mobile phase of 20% acetonitrile in water (containing 0.2 mM ammonium formate and 0.14% formic acid, pH 4) delivered in an isocratic mode. Tandem mass spectrometry operating in positive electrospray ionization mode with multiple reaction monitoring was used for quantification. The standard curves were linear in the concentration ranges of 0.5-100 ng/mL for granisetron and 0.1-100 ng/mL for 7-hydroxy granisetron in human plasma samples, and 2-2000 ng/mL for granisetron and 2-1000 ng/mL for 7-hydroxy granisetron in human urine samples, respectively. The accuracies were >85% and the precision as determined by the coefficient of variations was <10%. No significant matrix effects were observed for granisetron or 7-hydroxy granisetron in either plasma or urine samples. Granisetron was stable under various storage and experimental conditions. This validated method was successfully applied to a pharmacokinetic study after intravenous administration of 1 mg granisetron to a pregnant subject.

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Section: Resultsmentioning

confidence: 99%

Development and validation of a sensitive liquid chromatographic–tandem mass spectrometric method for the simultaneous analysis of granisetron and 7‐hydroxy granisetron in human plasma and urine samples: application in a clinical pharmacokinetic study in pregnant subject

Zhao

Chen

Caritis

et al. 2015

Biomedical Chromatography

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“…The result for granisetron is not in accordance with the literature. Under almost the same mass spectrometer conditions, using the same type of liquid chromatographic column, except for the different sample pretreatment, a mean ionization enhancement of 27% for granisetron was observed [19,20]. To account for this phenomenon, three different extraction procedures were used to evaluate the relations between the sample pretreatment procedures and matrix effects: an ethyl acetate liquid-liquid extraction, an acetonitrile protein precipitation and a solid phase extraction.…”

Section: Selectivitymentioning

confidence: 99%

Development of a liquid chromatography/tandem mass spectrometry assay for the determination of bestatin in rat plasma and its application to a pharmacokinetic study

Wang

Fan

Chen

et al. 2007

Journal of Chromatography B

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“…The literature reveals that several methods have been reported for determination of GRS in pharmaceutical preparations and biological fluids. These include high performance liquid chromatography (HPLC) using DAD (diode‐array detection),4 fluorescence,5–11 ultra‐violet (UV),12, 13 tandem mass spectrometric,14–19 and electrochemical10 detectors. A flow‐injection chemiluminescence method has been reported for the determination of granisetron 20…”

Section: Introductionmentioning

confidence: 99%

First derivative spectrophotometric determination of granisetron hydrochloride in presence of its hydrolytic products and preservative and application to pharmaceutical preparations

Hewala

Bedair

Shousha

2012

Drug Testing and Analysis

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Granisetron is a selective 5-HT3 receptor antagonist used in prevention and treatment of chemotherapy-induced nausea and vomiting. The drug is available in tablet dosage form and parenteral dosage form containing benzyl alcohol as a preservative. The main route of degradation of granisetron is through hydrolysis. The present work describes the development of a simple, rapid, and reliable first derivative spectrophotometric method for the determination of granisetron in presence of its hydrolytic products as well as the formulations adjuvant and benzyl alcohol. The method is based on the measurement of the first derivative response of granisetron at 290 nm where the interference of the hydrolytic products, the co-formulated adjuvant and benzyl alcohol is completely eliminated. The proposed method was validated with respect to specificity, linearity, selectivity, accuracy, precision, robustness, detection, and quantification limits. Regression analysis showed good correlation between the first derivative response and the concentration of granisetron over a range of 8-16 μg ml(-1) . Statistical analysis proved the accuracy of the proposed method compared with a reference stability indicating high performance liquid chromatography method. The described method was successfully applied to the determination of granisetron in different batches of tablets and ampoules. The assay results obtained in this study strongly encourage us to apply the validated method for the quality control and routine analysis of tablets and parenteral preparations containing granisetron.

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Rapid determination of granisetron in human plasma by liquid chromatography coupled to tandem mass spectrometry and its application to bioequivalence study

Cited by 26 publications

References 14 publications

Development and validation of a sensitive liquid chromatographic–tandem mass spectrometric method for the simultaneous analysis of granisetron and 7‐hydroxy granisetron in human plasma and urine samples: application in a clinical pharmacokinetic study in pregnant subject

Development and validation of a sensitive liquid chromatographic–tandem mass spectrometric method for the simultaneous analysis of granisetron and 7‐hydroxy granisetron in human plasma and urine samples: application in a clinical pharmacokinetic study in pregnant subject

Development of a liquid chromatography/tandem mass spectrometry assay for the determination of bestatin in rat plasma and its application to a pharmacokinetic study

First derivative spectrophotometric determination of granisetron hydrochloride in presence of its hydrolytic products and preservative and application to pharmaceutical preparations

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