LC determination of the anti-ulcer agent CDRI-85/92 in rat serum

CDRI-85/92 is a new potent anti-ulcer compound developed by Central Drug Research Institute, Lucknow (India). This compound is in advanced stage of preclinical trials. A High-performance liquid chromatographic (HPLC) method was developed and validated for the analysis of CDRI-85/92 using rat serum. The HPLC analysis, applicable to 0.5-ml volumes of serum, involved protein precipitation of serum samples with acetonitrile (1:3 v/v) followed by centrifugation and separation on a C-18 column and the use of UV detector at the wavelength 250 nm. The method was sensitive with a lowest limit of quantitation (LLOQ) of 1.25 ng ml(-1) in rat serum and the recovery was more than 96%. The linearity was satisfactory as indicated by correlation of >0.99, in addition to the visual examination of the calibration curves. The precision and accuracy were acceptable as indicated by relative standard deviation (R.S.D.) ranging from 4.15 to 8.21%, bias values ranging from 2.96 to 11.18%. In-process stability evaluation showed the stability of the compound in processed samples lasted up to 168 h. The method was applied for analysing CDRI-85/92 in rat serum after administration of single oral or iv bolus dose of 20 mg kg(-1). The robustness/ruggedness of the HPLC procedure was tested using different HPLC instrumentation and column of different make. The assay was found to be sensitive (limit of quantification was 1.25 ng ml(-1)), specific (retention time for CDRI-85/92 is 7.5 min), accurate (% bias is <12%), precise (% R.S.D. is <10%), robust (no significant change in peak profile in two HPLC Instruments) and reliable for use in pharmacokinetic or toxicokinetic studies.