One of the most common nervous system illnesses is headache disorders, which are characterized by chronic headaches. In Present investigation Almotriptan loaded Ethosomes were prepared by water phase addition method. The three independent factors including Phosphotidylcholine: Cholestrol: DSPE (6:3:1molar ratio), Surfactant concentration and sonication time. A factorial design 3*3(3 factor 3 level) was applied to prepare 17 formulation. Optimization of ethosomal preparation was carried out by applying Box Behnken response surface randomized factorial design following quadratic model using Design of Experiment (DOE) software version 11.04.0. The factor Soya PC: Cholesterol: DSPE in molar ration (6:3:1), Concentration of Tween-80 and sonication time were selected as dependable process and formulation factors that can be effect formulation characteristics like entrapment efficiency, average vesicle size, Polydispersity Index (PDI). All other factors like sonication speed and rotation speed was kept constant All the formulation were prepared by simple solvent evaporation thin film formation method and characterized for the drug entrapment, average vesicle size and PDI, shape morphology. Formulations were optimized on the basis of responses such as average vesicle size, PDI, and entrapment efficiency. All the characterized values of the responses were putted in the formulation design table and analyse to best fitted model for the design. It was observed that, quadaratic model is best fitted model for the design. The prepared ethosomes formulation can further incorporated in situ gel for effective treatment of migraine.
For the determination of Almotriptan malate in bulk and produced nasal in situ formulation, a new sensitive and quick HPLC technique was developed and validated according to ICH guidelines. The HPLC analysis was carried out using a waters system with a Thermo Scientific C18 (250 cm 4.6 mm) 5 m column and a mobile phase of acetonitrile: 20Mm KH2PO4 in an 80:20 v/v ratio, at a flow rate of 1.0mL/min. The detection was done at a wavelength of 282, and Almotriptan malate had a retention time of 5.658 minutes. The total time spent running was 10.0 minutes. Over the concentration range of 2-10 g/ml, the calibration plot revealed a linear relationship. The LOD and LOQ were 0.12 and 0.35μg, respectively. The accuracy of the proposed method was determined by recovery studies and was found to be near to 100 and % RSD value was found less than 2. The repeatability testing for both standard and sample solutions showed that the method is precise within the acceptable limits. RSD% of the determination of precision was less than 2%. The proposed method showed excellent linearity, accuracy, precision, specificity, LOD, LOQ, and system suitability results within the acceptance criteria. In addition, the main features of the developed method are low run time and retention time around 5 min.
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