Abstract

DEVELOPMENT & VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF FENSPIRIDE HYDROCHLORIDE IN BULK & PHARMACEUTICAL DOSAGE FORMS

O. S. S. Chandana*

ABSTRACT

A simple, specific, accurate, rapid, inexpensive isocratic RP-HPLC method was developed and validated for the quantitative determination of Fenspiride in bulk and formulation. The mobile phase was Acetonitrile: 10mM Ammonium acetate (50:50), effluent flow rate monitored at 1.0 ml/min with the responses measured at 210 nm. The stationary phase was Inertsil (250 x 4.6 mm, 5) analytical column. The solutions of standard and the sample were prepared in methanol. The retention time was found to be 4.67 min. Linearity was established for Fenspiride in the concentration range of 10-50 μg/mL with correlation coefficient 0.999. The percentage assay for Fenspiride was found to be 98.97 %. The LOD and LOQ were found to be 0.0072g/mL and 0.021 μg/ml. The method was validated and it was found to be accurate, precise, linear and reproducible.

Keywords: RP-HPLC, Fenspiride, Development, Accuracy, Precision, Linearity, Validation, System suitability, Robustness