DOI: 10.21276/ajptr
Thu, 23 May 2019

RP-HPLC Method Development and Validation of Regorafenib in Pure Form and Pharmaceutical Dosage Form

Kausik Bhar*, Padilam Suresh

School of Pharmacy, Guru Nanak Institutions Technical Campus, Ibrahimpatnam (M), Sagar Road, R. R. Dist., Hyderabad, Telangana, India, 501506.


ABSTRACT

A new, simple, accurate, precise and robust isocratic RP-HPLC method has been developed and subsequently validated for the determination of Regorafenib in pure form and pharmaceutical dosage forms as per ICH guidelines. The separation achieved on a Symmetry C18 Column, 250 mm x 4.6 mm i.d. and 5µm particle size column as a stationary phase and Methanol: Phosphate buffer (pH adjusted to 4.80 with phosphoric acid) in the ratio of 70:30v/v used as mobile phase at a flow rate of 1.0 ml/min. The UV detection was performed at 268nm. The retention time for Regorafenib was found to be 3.544minutes. The detector response was linear in the concentration range of 0-16µg/ml. The respective linear regression equation being Y= 58945.x + 9634 with R2 = 0.999. The percentage of Regorafenib in pharmaceutical dosage form was found to be within the limits. The limit of detection and the limit of quantification were found to be 0.90µg/ml and 2.90µg/ml respectively. The results of the study showed that, the proposed RP-HPLC method was simple, rapid, precise, accurate and stability indicating, which can be used for the routine determination of Regorafenib in pure form and pharmaceutical dosage forms.

Keywords: Regorafenib, RP-HPLC, Method Development, Validation, Precision, Accuracy, ICH Guidelines.

 


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