Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Sensitive and accurate method for chromatographic quantification of ibandronate in bulk and dosage forms

Sherif A Abdel-Gawad^1,2 , Hany H Arab³

¹Pharmaceutical Chemistry Department, College of Pharmacy, Prince Sattam bin Abdulaziz University, Al-Kharj-11942, Saudi Arabia; ²Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, ET-11562, Egypt; ³Department of Pharmacology and Toxicology, College of Pharmacy, Taif University, PO Box 11099, Taif 21944, Saudi Arabia.

For correspondence:- Sherif Abdel-Gawad Email: sagawad@yahoo.com

Accepted: 18 October 2021 Published: 31 January 2022

Citation: Abdel-Gawad SA, Arab HH. Sensitive and accurate method for chromatographic quantification of ibandronate in bulk and dosage forms. Trop J Pharm Res 2022; 21(1):137-141 doi: 10.4314/tjpr.v21i1.21

© 2022 The authors.
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Abstract

Purpose: To develop a simple, accurate and reproducible chromatographic method for determination of ibandronate.

Methods: Lack of chromophore groups in their structure is a problem with the determination of bisphosphonates. The developed method relies on chromatographic determination following derivatization of ibandronate with NBD-Cl. Separation and quantification of reaction products were done using HPLC system (LA CHROM MERCK HITACHI) composed of an isocratic pump (model L–7110) supplied with UV-visible wavelength detector (Model 7120) with Rheodyne injector (model 7161) and equipped with a 20-µL injector loop.

Results: Ibandronate was successfully derivatized with NBD-Cl to enhance its HPLC separation and quantification. The reaction conditions were optimized to achieve maximum sensitivity of the assay. The studied drug was satisfactorily quantified in the concentration range of 500 - 5000 ng/mL. Method validation was successfully performed in line with ICH directives in terms of robustness, accuracy, linearity and precision of the test method. The proposed method was satisfactory for the determination of ibandronate in either bulk and dosage forms.

Conclusion: An accurate and reproducible method for regular quantification of ibandronate has been developed, and it is suitable for use in analytical laboratories, including those of regulatory agencies.

Keywords: Ibandronate; HPLC; Analysis; Chromophore; Determination