RP-HPLC method with indirect UV detection for determination of sodium ibandronate in pharmaceuticals

Tanturovski, Zharko and Arsova-Sarafinovska, Zorica and Dimitrovska, Aneta (2019) RP-HPLC method with indirect UV detection for determination of sodium ibandronate in pharmaceuticals. Macedonian pharmaceutical bulletin, 64 (2). ISSN 1409 - 8695

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Ibandronate sodium (IBN) [(1-hydroxy-3- (methyl pentyl amino) propylidene bisphosphonic acid monosodium monohydrate)] is the sodium salt of ibandronic acid, a synthetic nitrogen-containing bisphosphonate drug. The aim of this study was to develop a sensitive and accurate RP-HPLC method for determination of IBN in pharmaceutical formulations. Chromatographic separation was performed on a Waters Bridge column C18 (250 mm x 4,6 mm I. D.; particle size 5 µm) in an isocratic mode with a mobile phase was consisted of 90 % buffer: 10 % ACN (v/v). The buffer was made using 1.5 ml ortho-phosphoric acid, 990 mg 1-hexanesulfonic acid sodium salt 98%, 140 mg EDTA in 1000 ml flask diluted with HPLC grade water. The elution was carried out at a flow rate of 1.0 mL/ min. A diode array detector measured the UV absorbance at 198 nm, in inverse mode.
The method was validated for specificity/ selectivity, linearity, LOD, LOQ, accuracy, precision, and robustness according to ICH validation guidelines. The limits of detection and quantification were calculated at 0.0163 µg/ml and 0.0495 µg/ml, respectively. The method was effectively used for determination of IBN from commercial tablets and provided good results without any interference from commonly used excipients.

Item Type: Article
Subjects: Medical and Health Sciences > Basic medicine
Natural sciences > Chemical sciences
Medical and Health Sciences > Other medical sciences
Divisions: Faculty of Medical Science
Depositing User: Zorica Arsova Sarafinovska
Date Deposited: 14 Jul 2020 15:48
Last Modified: 14 Jul 2020 15:48
URI: https://eprints.ugd.edu.mk/id/eprint/24208

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