Development of a sensitive high-performance thin-layer chromatography method for estimation of ranitidine in urine and its application for bioequivalence decision for ranitidine tablet formulations
| Autor: | S. S Savale, I. S Rathod, Shailesh A. Shah, Bipin D. Patel |
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| Rok vydání: | 2002 |
| Předmět: |
Clinical Biochemistry
Biological Availability Urine Bioequivalence Ranitidine Sensitivity and Specificity Biochemistry Analytical Chemistry Excretion Pharmacokinetics Reference Values medicine Humans High performance thin layer chromatography Chromatography Chemistry Reproducibility of Results Cell Biology General Medicine Crossover study Bioavailability Histamine H2 Antagonists Therapeutic Equivalency Area Under Curve Calibration Chromatography Thin Layer medicine.drug |
| Zdroj: | Journal of Chromatography B. 767:83-91 |
| ISSN: | 1570-0232 |
| DOI: | 10.1016/s0378-4347(01)00544-8 |
| Popis: | A sensitive and simple HPTLC method was developed for estimation of ranitidine in human urine. The drug was extracted from urine after basification using dichloromethane. Dichloromethane extract was spotted on silica gel 60 F254 TLC plate and was developed in a mixture of ethyl acetate-methanol-ammonia (35:10:5 v/v) as the mobile phase and scanned at 320 nm. The RF value obtained for the drug was 0.67 +/- 0.03. The method was validated in terms of linearity (50-400 ng/spot), precision and accuracy. The average recovery of ranitidine from urine was 89.35%. The proposed method was applied to evaluate bioequivalence of two marketed ranitidine tablet formulations (150 mg, Formulation I and Formulation 2) using a crossover design by comparing urinary excretion data for unchanged ranitidine in six healthy volunteers. Various pharmacokinetic parameters like peak excretion rate [(dAU/dt)max], time for peak excretion rate (tmax), AUC0-24, AUC0-infinity, cumulative amount excreted were calculated for both formulations and subjected to statistical analysis. The relative bioavailability of Formulation 2 with respect to Formulation 1 was 93.76 and 95.31% on the basis of AUC0-24 and cumulative amount excreted, respectively. Statistical comparison of various pharmacokinetic parameters indicated that the two ranitidine tablet formulations are bioequivalent. |
| Databáze: | OpenAIRE |
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