Development and Validation of Stability Indicating UV and RP-HPLC Method for The Estimation of Flupritine maleate in Bulk and Formulp.tions

摘要

The objective of the study was to develop stability indicatingUV spectroscopy and RP-HPLC method for the estimation of flupritine maleate in bulk and marketed tablets. Chromatographic separation was achieved on Agilent Eclipse C18, 150 x 4.6 mm, 5m with mobile phase consisting of Buffer(1ml OPA and 1ml TEA in 1000 ml water and pH was adjusted to 3 with dilute OPA) and Methanol are taken in 50:50%v/v. The effluent was monitored at 246 nm. A sharp peak was observed at 4.0 min. UV Spectrophotometry method was performed at 250 nm using methanol as the solvent. R~2=0.999 for HPLC method and R~2=0.998 for UV Spectrophotometry method. The method was validated as per ICH guidelines with linearity, precision, accuracy, robustness, ruggedness and specificity.Statistical analysis showed that both the methods were precise, accurate, sensitive, and Stability indicating can be used for the routine analysis of flupritine economically in bulk and commercial formulations.