METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF PLERIXAFOR BY RP-HPLC METHOD IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMAbstract
A simple, precise and accurate RP-HPLC method was developed for the determination of Plerixafor in bulk and pharmaceutical dosage forms. The estimation was carried out on Xterra RP 18 (4.6 x 250mm, 5µm) column using a mixture of Methanol: Water (50:50% v/v) as the mobile phase at a flow rate of 0.8ml/min, the detection was carried out at 215nm. The method was validated for linearity, accuracy, precision, specificity, limit of detection and limit of quantification and robustness as per ICH norms. The retention time of the Plerixafor was 5.481 min. The method produce linear responses in the concentration range of 10-50mg/ml with correlation coefficient (r2) of 0.999. The proposed method is useful for the estimation of plerixafor in its pure and injection dosage forms.