A Rapid Assay of Granisetron in Biological Fluids from Cancer Patients.

Wada, Ikuo; Satoh, Michiko; Takeda, Takeo; Nakabayashi, Takehito; Honma, Teruki; Shinmoto, Hiroshi; Hirano, Kazuyuki

doi:10.1248/bpb.21.535

Cited by 11 publications

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“…The bedridden elderly patients in this study were in the terminal stage of lung cancer, and it was, therefore, probable that they had extracellular fluids like thoracic effusion and edema as the third space for the distribution of GRN. In a recent paper, 7) we reported that intravenously administered GRN was rapidly and highly distributed throughout the pleural effusion and then disappeared from the pleural effusion in a two-compartment model. It might be assumed that an elimination route of GRN, which distributed into the third space, is back-diffusion into the blood-stream.…”

Section: Resultsmentioning

confidence: 95%

“…The HPLC system used was a Shimadzu LC-10A (Kyoto, Japan) equipped with a Shimadzu RF-10A fluorescence detector and Shimadzu CTO-10A column oven. Chromatographic condition were as follows: 7) column, LiChroCART ® packed with LiChrospher 100CN (CicaMerck, 250ϫ4 mm i.d., 5 mm); mobile phase, 0.1 M acetate buffer (pH 3.5)-acetonitrile (7 : 3); flow rate, 1 ml/min; column temperature, 40°C; detector, 290 nm for excitation and 365 nm for emission.…”

Section: Methodsmentioning

confidence: 99%

“…6) We recently developed a rapid and reliable assay method for measuring GRN in serum and urine by HPLC. 7) In this study, we determined GRN levels in serum and/or urine from seven adult patients with lung cancer and seven child patients with malignant disease following intravenous infusion, and evaluated their pharmacokinetic parameters.…”

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confidence: 99%

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Pharmacokinetics of Granisetron in Adults and Children with Malignant Diseases.

Wada

Takeda

Sato

et al. 2001

Biological & Pharmaceutical Bulletin

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Granisetron (GRN) is widely used for patients with various cancers who suffer from chemotherapy-induced vomiting and nausea. The, pharmacokinetics of GRN has not been fully evaluated in such patients, however, and its dosage regimen is still controversial. In this study, we determined GRN levels in serum and urine from lung cancer patients and children suffering from cancer after intravenous infusion. In lung cancer patients, the interindividual variations in t 1/2b b , area under the concentration-time curve (AUC ), and Vd b b were relatively smaller than expected from previous reports on healthy subjects, while t 1/2b b was prolonged more than 5-fold in healthy subjects. Urinary excretion of unchanged GRN in lung cancer patients was ca. 15% of dose, consistent with previous reports, and one individual demonstrated an even higher urinary excretion (ca. 45%). The pharmacokinetic parameters of GRN in child cancer patients varied markedly among individuals, and some child patients had smaller t 1/2b b than adult patients. In these cases, GRN should be administered at shorter intervals. These results suggested that a pharmacokinetic study of GRN was necessary for planning a dosage regimen and managing chemotherapy-induced vomiting and nausea.

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Section: Resultsmentioning

confidence: 95%

Section: Methodsmentioning

confidence: 99%

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Pharmacokinetics of Granisetron in Adults and Children with Malignant Diseases.

Wada

Takeda

Sato

et al. 2001

Biological & Pharmaceutical Bulletin

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“…4 A review of the literature revealed no methods for determination of granisetron in pharmaceutical dosage forms and dissolution medium and previously reported methods were mainly focused on the analysis of this drug in biological fluids. Previous studies have reported HPLC methods with fluorescence detection [5][6][7][8] and LC-MS/MS methods 9,10 for determination of granisetron in human biological fluids. According to the International Conference on Harmonization (ICH) guidelines 11 and USP, 3 the assay method for determination of an active substance should be stability indicating to evaluate the drug in the presence of its degradation products.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Stability Indicating HPLC Method for Determination of Granisetron

Souri

Kargar

Saremi

et al. 2011

J Chinese Chemical Soc

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The aim of this study was to study the stress degradation of granisetron and analysis of the drug in the presence of its degradation products. Forced degradation studies were conducted on bulk sample using acidic, alkaline, oxidative, heat and photolytic conditions. Granisetron was relatively unstable under acidic, alkaline and oxidative conditions. Separation of granisetron and degradation products was achieved using a Nova-Pak C 8 column and acetonitrile-KH 2 PO 4 25 mM (75:25, v/v) as mobile phase with UV detection at 305 nm. The method was linear over the range of 0.2-15 mg/mL granisetron (r 2 > 0.999). The within-day and between-day precision values were also in the range of 0.5-4%. The proposed method was successfully applied for quantitative determination of granisetron in tablets and in vitro dissolution studies.

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“…H and 13 C NMR and 2D NMR spectral data. The HPLC chromatographic conditions were chosen to achieve satisfactory resolution between the impurities and API with shortest analysis time.…”

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2017

IJPSR

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ABSTRACT:The objective of the present study is to identification of the oxidative degradation impurity in the Granisetron hydrochloride active ingredient and also the novel method developed based on the forced degradation studies performed on Granisetron Hydrochloride to well resolve the impurities from the API. Forced degradation studies were conducted as per ICH technical requirements prescribed stress conditions using acid, base, oxidative, thermal stress, and photolytic degradation to show the stability indicating power of the method. Significant degradation was observed during basic hydrolysis and in oxidative studies and no degradation was observed in other stress conditions. Characterization of oxidative degradation impurity was conceded with a combination of analytical and preparative LC isolation followed by LC-MS/MS, IR and 1 H and 13 C NMR and 2D NMR spectral data. The HPLC chromatographic conditions were chosen to achieve satisfactory resolution between the impurities and API with shortest analysis time. Granisetron hydrochloride and its impurities were separated on Xbridge phenyl column (150mm×4.6 mm, 3.5 microns particle size). The mobile phase A composed of 10mM of Ammonium acetate in water (pH 8.5) and mobile phase B is Acetonitrile: Methanol (50:50, v/v) pumped at flow rate of 1mL/min with gradient. The column temperature was set at 40 °C and the detection wavelength at 305nm using UV detector. The developed HPLC method is suitable for LC-MS analysis which was further used to characterize the degradation products. Validation of the new developed HPLC-UV method was carried out in accordance with ICH guideline and met all required acceptance criteria.

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A Rapid Assay of Granisetron in Biological Fluids from Cancer Patients.

Cited by 11 publications

References 0 publications

Pharmacokinetics of Granisetron in Adults and Children with Malignant Diseases.

Pharmacokinetics of Granisetron in Adults and Children with Malignant Diseases.

Development and Validation of a Stability Indicating HPLC Method for Determination of Granisetron

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