ANALYTICAL METHOD OF DEVELOPMENT AND VALIDATION FOR ESTIMATION OF IMIPRAMINE AND CHLORDIAZEPOXIDE IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

M. Sri Vidya* and A. Yasodha

ABSTRACT

The analytical method was developed by studying different parameters. First of all, maximum absorbance was found to be at 251 nm and the peak purity was excellent. Injection volume was selected to be 20μl which gave a good peak area. The column used for study was Phenomenex Gemini C18 (4.6×250mm) 5μm particle size because it was giving good peak. 35º C temperatures was found to be suitable for the nature of drug solution. The flow rate was fixed at 1.0ml/min because of good peak area and satisfactory retention time.Mobile phase is Methanol and Phosphate buffer (pH-3.8) (40:60% v/v) was fixed due to good symmetrical peak. So this mobile phase was used for the proposed study. Run time was selected to be 6 min because analyze gave peak around 2.121, 3.643 ±0.02min respectively and also to reduce the total run time. The percent recovery was found to be 98.0-102% was linear and precise over the same range. Both system and method precision were found to be accurate and well within range. The analytical method was found linearity over the range 10-30mg/ml of Imipramine and 30- 90mg/ml of Chlordiazepoxide of the target concentration. The analytical passed both robustness and ruggedness tests. On both cases, relative standard deviation was well satisfactory.

Keywords: Imipramine, Chlordiazepoxide, RP?HPLC, Simultaneous estimation.