SIMPLE RP-HPLC METHOD DEVELOPMENT FOR THE ESTIMATION OF ALMOTRIPTAN MALATE IN NASAL IN-SITU FORMULATION

Abstract

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.