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%.
Dwivedi
A K
AK
Division of Pharmaceutics, Central Drug Research Institute, Chhattar Manzil Palace M.G. Marg, Lucknow 226001, India. a_k_dwivedi1957@rediffmail.com
Saxena
D
D
Saxena
A K
AK
Singh
S
S
D002138:Calibration; D002317:Cardiovascular Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D010879:Piperazines / Q000032:analysis*; D011760:Pyrrolidinones / Q000032:analysis*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet
C439505:1-(4-(4-fluorophenyl)piperazine-1-yl)-3-(2-oxopyrrolidin-1-yl)propane; D002317:Cardiovascular Agents; D007202:Indicators and Reagents; D010879:Piperazines; D011760:Pyrrolidinones; D012996:Solutions