A rapid, sensitive and simple reversed-phase high-performance liquid chromatographic (HPLC) method has been developed and validated for the determination of acyclovir (ACV) in rabbit plasma. BDS C18 column was used to conduct analysis using ammonium dihydrogen phosphate buffer (50mM) and methanol as mobile phase (98:2), with pH adjusted to 2.5 using orthophosphoric acid. Flow rate was kept at 1 mL/min. Selective precipitation of plasma proteins were done by adding 5% perchloric acid. Precipitated plasma proteins were separated by centrifugation. ACV moves in a supernatant, which was snapped and passed through a syringe filtration assembly. Direct injection of supernatant was given into a BDS C18 column and ACV was detected at 256 nm. The limit of detection for ACV in plasma was estimated as 15ng/mL whereas the limit of quantitation was calculated as 25 ng/mL. Moreover, the developed method has been found to be selective and linear into concentration range of 25 – 2000 ng/mL. The present method could be successfully applied to samples from bioavailability and bioequivalence studies.
Xanthan gum-based hydrogel formulation FXG3 was prepared by a free radical polymerization technique. To assess safety of FXG3 hydrogel for potential application as new drug delivery system, a single oral dose toxicity study was conducted according to OECD guidelines. Female adult rats of Wistar strain were divided into group A and group B. Group A served as the control and was given 1mL/100 g body weight 0.9% saline. Group B received a dose of 5g/kg body weight of FXG3 hydrogel. Rats were observed continuously for 14 days for clinical signs, and prior to terminal sacrifice, blood samples were taken to assess for haematology and biochemical parameters. Selected organs (heart, liver, lung, kidneys, spleen, and stomach) were removed and examined macroscopically, washed, sliced and stained with haematoxylin-eosin for histopathological investigation. No mortality or any signs of acute toxicity was observed during the observation period. No macroscopic alteration was found in the selected organs. Histopathological examination did not show any pathological changes. Thus, the maximal tolerated dose of FXG3 was calculated to be higher than 5g/kg body weight. It can be concluded that FXG3, a xanthan gum-based hydrogel formulation, was non-toxic after acute oral administration at 5g/kg body weight, and thus may be a promising candidate in controlled drug delivery system.
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