Assay method for quality control and stability studies of a new CVS disorder agent (compound 93/478)

1-[4-(4-fluorophenyl)-piperazine-1-yl]-3-(2-oxopyrrolidin-1-yl)-propane hydrochloride, (I), (CDRI code No. 93/478) is a new potent anti-ischemic and anti-hypertensive agent, being developed at the Central Drug Research Institute (CDRI), Lucknow, India. A sensitive high performance liquid chromatographic assay method has been developed and validated for in process quality control and for stability studies. HPLC separation was achieved on a C(18) Purospher (Merck) column using a gradient of 0.02% tetra-methyl ammonium hydroxide (pH 7.5) and acetonitrile as mobile phase. The eluents were monitored by diode array detector at 240 and 290 nm. The lower limit of detection of I was 0.62 microg/ml, while the lower limit of quantitation was set to be 1.5 microg/ml. The calibration curves were linear in the range 1.5-62 microg/ml. Reproducibility of the method was determined by inter and intra assay variation, which were <10%.