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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Abstract
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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