To Develop and Validation of RP-HPLC Method for Estimation of Mycophenolate Mofetil in Pure and Pharmaceutical Tablet Dosage

Description

Abstract (English)

Abstract
The present work is aimed at development and validation of RP HPLC method which is
simple, specific, precise, and accurate for estimation of Mycophenolate Mofetil and its
process-related impurity in bulk and pharmaceutical dosage forms. Extensive literature
survey revealed no method for estimation of the above said. The characterization of
synthesized impurities detected by using FTIR, NMR and MS. The RP-HPLC method was
developed according to ICH Q2B guidelines for quantitation of impurity in bulk and
formulations. The method was validated as per ICH guidelines. The method was found to be
linear, precise, accurate, robustand rugged. The present study focuses on the various steps,
parameters involved in HPLC condition. Various applications of this system also discussed.
HPLC process development is important in case of drug discovery, drug development and
pharmaceutical products. It can be adopted apparently for routine quality control study of
research and formulation tests. The method is carried out on a Symmetry C18 (4.6 mm ID ×
150 mm, 5 µm, Make: X-Terra) with a mobile phase consisting of aceton itrileand potassium
di-hydrogen phosphate buffer of pH=4.0 in the ratio 65:35 volume/ volume at a flow rate of
0.7mL/min. The detection of eluted components is carried out at a wavelength of 216 nm.
The retention time of mycophenolate mofetil is found to be 2.647min.The developed method
is validated in terms of accuracy, precision, linearity, limit of detection, limit of quantization.
The linearity limits, LOD and LOQ of the developed method are found to be 10-50, 0.052
and 0.171 µg mL-1 , respectively. The developed method is found to be simple, fast and
economic and hence it can be used as an alternative method in quality control.