PubMed · 814796
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J K Penry. 1975. Perspectives in complex partial seizures.. https://pubmed.ncbi.nlm.nih.gov/814796/
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The Bioanalytical Chemistry Department at the Madison facility of Covance Laboratories, has developed and validated a simple and sensitive method for the simultaneous determination of phenytoin (PHT), carbamazepine (CBZ) and 10,11-carbamazepine epoxide (CBZ-E) in human plasma by high-performance liquid chromatography with 10,11 dihydrocarbamazepine as the internal standard. Acetonitrile was added to plasma samples containing PHT, CBZ and CBZ-E to precipitate the plasma proteins. After centrifugation, the acetonitrile supernatant was transferred to a clean tube and evaporated under N2. The dried sample extract was reconstituted in 0.4 ml of mobile phase and injected for analysis by high-performance liquid chromatography. Separation was achieved on a Spherisorb ODS2 analytical column with a mobile phase of 18:18:70 acetonitrile:methanol:potassium phosphate buffer. Detection was at 210 nm using an ultraviolet detector. The mean retention times of CBZ-E, PHT and CBZ were 5.8, 9.9 and 11.8 min, respectively. Peak height ratios were fit to a least squares linear regression algorithm with a 1/(concentration)2 weighting. The method produces acceptable linearity, precision and accuracy to a minimum concentration of 0.050 micrograms ml-1 in human plasma. It is also simple and convenient, with no observable matrix interferences.
Results of the development of a solid dosage form containing 200 mg Carbamazepine (CBZ) are presented. Citric acid and low substituted Hydroxypropyl-cellulose (L-HPC) were used as dissolution enhancers of the active ingredient. Granulation the CBZ and citric acid with water has no effect on the dissolution of CBZ, but the granulation with absolute alcohol increases the dissolution rate. This enhancement could be explained with a molecular interaction between the CBZ and citric acid in water-free media. This interaction is indicated by the melting points, IR-spectra and scanning electron microscopy of the materials and granules. Further dissolution enhancement can be reached with L-HPC because of its disintegrating effect on the granules. Application of citric acid and L-HPC together results in extremely fast dissolution of the CBZ.
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