Abstract

D. Gowrisankar¹, N. Mallikarjuna Rao*²

DOI : http://dx.doi.org/10.13005/ojc/300455

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(1 ml OPA and 1 ml 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 Spectrophotometric method was performed at 250 nm using methanol as the solvent. R²=0.999 for HPLC method and R²=0.998 for UV Spectrophotometric 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.

Flupritine maleate; RP-HPLC; UV-Spectrophotometric; Method development and validation; Degradation; ICH guidelines

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