Journal of Developing Drugs
Open Access
ISSN: 2329-6631
+44 1478 350008
ISSN: 2329-6631
+44 1478 350008
Mohammed Kaleemullah, Yusrida Darwis, Peh Kok Yang, Mallikarjun Chitneni, Jiyauddin Khan, Fadli Asmani and Eddy Yusuf
Universiti Sains Malaysia, Malaysia
Jurox Pty Ltd, Australia
Management & Science University, Malaysia
Posters & Accepted Abstracts: J Develop Drugs
The present study was aimed to develop, validate a simple reversed-phase high performance liquid chromatographic method for determination of sulpiride in plasma and also to evaluate in vivo performance of the optimized gastroretentive formulation in comparison with a non-gastroretentive reference product (Dogmatil�®) using rabbits as an animal model. The HPLC system was operated at an excitation and emission wavelengths of 300 nm and 365 nm, respectively with the gain was set at 4 and sensitivity at medium. The mobile phase was consisted of 0.01 M phosphoric acid, acetonitrile and methanol (84:12:4, v/v) with addition of Triethylamine (0.15%v/v). The mobile phase pH was adjusted to 6 by using glacial acetic acid. The mobile phase was isocratically pumped at a flow rate of 1 mL/min. The analytical column Luna C18 (5 �¼m, 250 x 4.6 mm ID, Phenomenex, USA) fitted with a refillable guard column (Upchurch Scientific, Oak Harbour, WA, USA) packed with Perisorb RP-18 (30-40 �¼m, pellicular) was used for chromatographic separation. The mobile phase was filtered under vacuum through 0.45 �¼m nylon membrane filter (Whatman International, England) and degassed before used. The calibration curve was linear in the range of 15 to 4000 ng/ml with correlation coefficient (r) of 0.9999 (�±0.0001). The intraday accuracy ranged from -4.59% to 12.91% with a precision from 1.42% to 6.79%. The inter-day accuracy ranged from -1.86% to 6.29% with a precision from 4.21% to 13.91%. The extraction recovery values were found to be 95.99�±9.44%, 96.12�±11.94% and 93.49�±5.13%, with precision of 9.84%, 12.42% and 5.49% respectively. The mean recovery for internal standard (metoclopramide) was 90.28�±3.95%. The values of accuracy, precision and recovery obtained were within the acceptable limits as proposed by USFDA Bioanalytical Guidelines. For in vivo pharmacokinetics study a balanced two-way crossover design was used using 6 rabbits. The optimized formulation had higher Tmax, and AUC0-â�� values but lower Cmax value than non-gastroretentive reference product (Dogmatil�® capsule). The bioavailability of sulpiride in the optimized gastroretentive dosage form was 2.20 times higher than the non-gastroretentive reference product (Dogmatil�® capsule). In addition, the amount of drug released in vitro was correlated with the amount of drug absorbed in vivo.
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