A VALIDATED STABILITY INDICATING REVERSE PHASE -HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF FELBINAC
The aim of the present study is to develop a stability-indicating assay method for the determination of Felbinac after being subjected to different ICH prescribed stress conditions, such as hydrolysis, oxidation, heat, and photolysis. Felbinac (Biphenyl-4-yl) acetic acid is decomposed under hydrolytic stress (acidic, and alkaline), oxidative stress and under thermal condition. An isocratic – reverse phase high performance liquid chromatography (HPLC) method was developed to separate the drug from the degradation products, using the HPLC system consisted of a pump (Jasco PU-2089 plus Quaternary Gradient Pump), a UV/Vis detector (Jasco UV-2075 Plus intelligent UV/Vis detector) with a C-18 column (Finepak SIL, 250 x 4.6 mm, 5 μm) using acetonitrile: phosphate buffer pH 3.5 (60:40 v/v) as mobile phase and flow rate 1.0 ml/min with UV detection at 273 nm. The HPLC software used was Jasco-ChromNAV (1.19.1 Version). The linearity of the proposed method was investigated in the range of 20-120μg mL-1 (r2 =0.9997) for felbinac. The limit of detection was 0.1μg mL-1 and limit of quatitation was 1μg mL-1. The percentage recovery of felbinac was ranged from 98 to 100.8%. The %R.S.D. value for intraday precision study was <0.5% and for inter-day study were <1.5% confirming that the method was sufficiently precise; Robustness of the method was done by changing the flow rate and pH of the Mobile phase. The %R.S.D. value for robustness study was <1.0%. The validation studies were carried out fulfilling International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intra and inter day precision), accurate and robust