Journal :   Asian Journal of Research in Chemistry

Volume No. :   11

Issue No. :  4

Year :  2018

Pages :   763-767

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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



Address:   Jitendra Debata1*, Pratap Kumar Patra2, P. Suresh1
1Gurunanak Institutions Technical Campus-School of Pharmacy, Sagar Road, Ibrahimpatnam (M),
Rangareddy (D), Hyderabad, Telangana, India.
2Sree Dattha Institute of Pharmacy, Sheriguda, Ibrahimpatnam, Rangareddy (D), Hyderabad, Telangana, India
*Corresponding Author
DOI No: 10.5958/0974-4150.2018.00134.7

ABSTRACT:
A new, simple, accurate, precise, robust and 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 mmx4.6 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.
Cite:
Jitendra Debata, Pratap Kumar Patra, P. Suresh. RP-HPLC Method Development and Validation of Regorafenib in pure Form and Pharmaceutical Dosage Form. Asian J. Research Chem. 2018; 11(4):763-767.
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