Formulation, Evaluation and Validation of Oral Film for The Treatment of Antimigraine by Using HPLC Method

The aim of the present study was formulated, evaluate and validation of oral film by using HPLC. In the present study, the oral film of Zolmitriptan 5 mg was prepared by Solvent casting method using HPMC E-15 and HPMC E5 as a film forming polymer, Glycerin as a plasticizer, saccharin as a sweeting agent, Citric acid as a preservatives and Sodium starch glycolate is a super- disintegrator. Other formulation ingredients are also used in the formulation. Total five formulations (F1 to F5) were prepared by solvent casting method. Among these two formulations F4 show lower results and F5 show results on higher side. So, the formulations F5 were taken as optimize formulations in this study. The present study describes the development and validation of HPLC (HILIC) Mixed Mode method for determination of an Zolmitriptan. The separation was achieved by using ZIC-HILIC Mixed Mode (5µm; 150 x 4.6 mm ID.column by using solvent A; 15mM ammonium acetate solvent B; acetonitrile (50:50, v/v) as mobile phase with the flow rate of 0.9ml/min. Where detection was carried out by UV detector (SPD-10AVP) at 225nm. The retention time was found to be 4.23 min. The described method was linear over the range of 3.18 – 100 µg/ml. The mean regression equation was found to be y =245511 + 428133, R 2 = 0.9994. The precision, ruggedness, accuracy, repeatability, robustness values were also within the prescribed limits. The developed HILIC Mixed Mode method was validated as per the ICH guidelines.