Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Ultrafast monolithic HPLC method for simultaneous quantification of the anticancer agents, imatinib and sorafenib: Application to tablet dosage forms

Hassan A Alhazmi¹ , Dhaif Allah Moraya¹, Emad Alahdal¹, Mohammed Kariri¹, Mohammed Al Bratty¹, Ziaur Rehman^1,2, Sadique A Javed¹

¹Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan 45142, Saudi Arabia; ²Department of Pharmacy, IBMER, Mangalayatan University, 33rd Milestone, Beswan, Aligarh 202145, India.

For correspondence:- Hassan Alhazmi Email: haalhazmi@jazanu.edu.sa Tel:+66541433344

Accepted: 17 May 2018 Published: 30 June 2018

Citation: Alhazmi HA, Moraya DA, Alahdal E, Kariri M, Bratty MA, Rehman Z, et al. Ultrafast monolithic HPLC method for simultaneous quantification of the anticancer agents, imatinib and sorafenib: Application to tablet dosage forms. Trop J Pharm Res 2018; 17(6):1127-1134 doi: 10.4314/tjpr.v17i6.20

© 2018 The authors.
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Abstract

Purpose: To develop and validate a simple ultrafast monolithic high performance liquid chromatography (HPLC) method for the simultaneous quantification of two anti-cancer agents, imatinib and sorafenib, in pure form and tablet preparations.

Methods: Chromatographic separation was accomplished using Chromolith flash RP-18 HPLC-column (25 - 4.6 mm; macropores, 2 µm; mesopores, 13 – 15 nm). The optimum mobile phase composition of ammonium acetate buffer (10 mM, pH 8.5) and methanol at ratio of 35:65 v/v was used. Effluent flow rate was adjusted to 1.0 mL/min and the analysis was performed at 250 nm wavelength. The developed method was evaluated for specificity, linearity, precision and accuracy.

Results: The method offered a linear relationship over the concentration range of 1 - 16 µg/ml (correction coefficient, R² = 0.9999) for both analytes. Limit of detection (LOD) was 0.1891 and 0.1888 µg/ml while limit of quantification (LOQ) was 0.6303 and 0.6294 µg/ml for imatinib and sorafenib, respectively. Mean recovery was within 100 ± 2 %. The utility of the new method was demonstrated by its successful use for the analysis of commercially available tablet formulations of both drugs.

Conclusion: The developed method is fast and economical, and is being recommended for routine analysis of imatinib and sorafenib in bulk drug and tablet dosage forms in quality control laboratories.

Keywords: RP-HPLC, Chromolith, Imatinib, Sorafenib, Validation, Quality control