Analytical method development and validation of plerixafor in its dosage form in the presence of tetra-aza-cyclotetra decane derivatives by HPLC
DOI:
https://doi.org/10.61096/ijpar.v7.iss4.2018.543-557Keywords:
Plerixafor, HPLC method, Quantification, Formulation, Related substancesAbstract
A simple and selective HPLC method is described for the determination of plerixafor Chromatographic separation was achieved on a Zorbax eclipse C 18 250x4.6mmx5 micron using mobile phase consisting Water: Methanol: Acetonitrile in the ratio 40:35:25v/v with detection wavelength of 221 nm. Linearity was observed in the range 50-125 µg /ml For Plerixafor (r2 =0.9964) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed method is fully validated with parameters like accuracy, precision, linearity, limit of detection, limit of quant ification, robustness and ruggedness. The proposed method is stability indicating with parameters like acid base peroxide, photolytic and thermal degradation. No interference found from all three impurities of Plerixafor that is tetraazacyclotetradecane derivatives.