A single dose pharmacokinetic study was conducted on two sustained-release formulations (75 mg) of indomethacin (Indocid capsules 'A' and Indogesic tablets 'B'). The study was carried out on 22 healthy male volunteers, who received a single oral dose (75 mg) of each product according to a randomized crossover design. Blood samples were obtained over a 24 h period, and drug concentrations were determined by an HPLC assay. The two products were not found to be statistically different with respect to the lag time between dosing and first appearance of the drug in the serum (1.0 +/- 0.1 and 0.9 +/- 0.1 h for A and B, respectively), or in the time needed to attain the peak concentrations (3.3 +/- 0.3 and 3.3 +/- 0.5 h for A and B, respectively). The two products, however, varied significantly in the peak serum concentrations (2721 +/- 220 and 1797 +/- 129 ng/ml for A and B, respectively). In terms of the extent of absorption, assessed by estimating the area under the concentration-time curve over 24 h, the two products were not found to be significantly different (11,575 +/- 630 and 10,212 +/- 556 ng . h/ml for A and B, respectively). Based on these findings, the two formulations can be considered bioequivalent in the extent but not in the rate of drug absorption.
The main objective of this study was to establish a chromatographic method for analysis, determination and standardization of the two main components vanillic acid and luteolin as major components in Paronychia argentea Lam dry extract. This analytical method was designed to be a simple and fast with an appropriate separation of the two main components of the extract. High pressure liquid chromatography (HPLC) method of analysis was developed to quantitatively determine, identify and standardize the two main active constituents in the pharmaceutical dry extract against luteolin and vanillic acid as primary reference standards as it is the major active constituents of the dry extract of P. Argentea, where the linearity obtained was higher than R2 = 0.99981 and 0.99908 respectively. Although the method was proven to be suitable, further specific analysis validation was conducted to include the following: linearity, precision, range, limit of detection, limit of quantitation and filter compatibility. The luteolin and vanillic acid were completely separated from the other components in the herbal dry extract with an Rf value of 1.3 and 5.7 minutes respectively. The concentration of Luteolin is 0.4% while vanillic acid content is 0.1% in the dry extract.
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