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Sensitive HPLC Method For Biovailability And Bioequivalence Studies Of Theophylline SR Formulations

Author(s): C. J Shishoo, S. S Savale

As part of ongoing programme on the development of a sustained release (SR) formulation of theophylline (200 mg capsule) and determination of its bioavailability, a specific, sensitive and simple HPLC method has been developed for the estimation of lower mg levels of theophylline in plasma. 8-Chlorotheophylline was used as an internal standard. With simple extraction of theophylline from plasma, the method has a, linearity range of 0.5 to 30 mg/ml and an average recovery of 79.32% for theophylline and 88.49% for the internal standard, respectively. Theophylline plasma concentration versus time data is presented for the test formulation (T) (SR capsule, 200 mg) and a standard formulation (S) (SR tablet, 200 mg). Different pharmacokinetic parameters for formulation T and formulation S were estimated and compared statistically for determination of their bioequivalence.


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Citations : 53647

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