Development and validation of liquid chromatographic method for quantitative determination of Loxoprofen in mobile phase and in human plasma

ABSTRACT

A Simple, sensitive and accurate high-performance liquid chromatographic [HPLC] method for effective and specific analysis of Loxoprofen [LXP] in the mobile phase and human plasma was developed. Effective chromatographic separation was attained on a Mediterranea Sea C18 column [250×4.6mm, 5um] with mobile phase containing acetonitrile and 0.01 M NaH2PO4 buffer [55 45] by adjusting pH 6.5 with sodium dihydrogen phosphate buffer at a flow rate of 1ml/ min. Calibration ranges from 0.1ppm to 10 ppm with a coefficient of relation value [R2=0.999] by using a linear regression method and lower limit of quantification was 0.1ppm. The current method showed inter-day and intra-day accuracy and precision within the range of +/- 10%. % RSD was found to be less than 5 %. Analytical recovery was more than 90% which confirmed the reliability of current method. The proposed method was found appropriate for assessment of LXP in pharmacokinetic and bioequivalence study