Volume 8 | Issue - 8
Volume 8 | Issue - 8
Volume 8 | Issue - 8
Volume 8 | Issue - 7
Volume 8 | Issue - 7
This study was aimed for the formulation development, optimization and evaluation of parenteral preparation for migraine treatment. A preformulation study for assay of model drug was conducted by characterization of active pharmaceutical ingredient done by IR showing numerous level of stretching between C-C, C-H, C=O, C-N and UV spectroscopy where calibration curve was prepared and R2 value was found 0.996, it shows the linearity between 10 µg/ml to 90 µg/ml. Forced degradation study was performed which concluded that model drug is susceptible for acidic, alkaline, oxidation and thermal. Drug excipient compatibility studies found that glycerin from spectrum and ethanol from Hayman is providing the satisfactory impurity profile while kept under stress condition. The tentative manufacturing process flow results reflected that there was significant increase in the Impurity C & D at 40/75%RH –1 month. Two batches were prepared by purging N2 and CO2 and it has been estimated that the Methane sulphonic acid (MSA) was consumed more in case of batch prepared under CO2 purging. Hence N2 as inert gas was recommended. Evaluation of the developed batch concluded that batch passes the osmolality test. However, the results of liquid particle count of developed batch also pass all the parameter of USP.