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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 with indirect UV detection for determination of IBN in pharmaceutical formulations. Chromatographic separation was performed on a Waters Bridge C18 reversed-phase column (250 x 4.6 mm I.D.; particle size 5 µm), in an isocratic mode with a mobile phase constituted of 90% buffer: 10% acetonitrile (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 minˉ1. 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. Keywords: RP-HPLC with indirect UV detection, Ibandronate sodium, validation, pharmaceuticals
Highlights
Ibandronate sodium (IBN) is the sodium salt form of ibandronic acid, a synthetic nitrogen-containing bisphosphonate (Fig. 1)
The buffer was made using 1.5 mL ortho-phosphoric acid, 990 mg 1-Hexanesulfonic acid sodium salt 98%, 140 mg ethylenediaminetetraacetic acid (EDTA) in 1000 mL flask diluted with high-performance liquid chromatography (HPLC) grade water
Several analytical methods using refractive index or electrochemical detection were described in the literature (Brooks et al, 1992; Denhartigh et al, 1993; Han et al, 1996; Higuchiet al., 1992)
Summary
Ibandronate sodium (IBN) is the sodium salt form of ibandronic acid, a synthetic nitrogen-containing bisphosphonate (Fig. 1). Ibandronic acid inhibits farnesyl pyrophosphate synthase, resulting in a reduction in geranylgeranyl GTPase signaling proteins and apoptosis of osteoclasts. This agent increases bone mineral density, decreases bone remodeling, inhibits osteoclast-mediated bone resorption, and reduces metastases-related and corticosteroidrelated bone pain (Bausset al., 2002; Black et al, 2007). Several analytical methods using refractive index or electrochemical detection were described in the literature (Brooks et al, 1992; Denhartigh et al, 1993; Han et al, 1996; Higuchiet al., 1992). These detection systems are not common in most of the routine analytical laboratories. The derivatization step is time and solvent consuming, making this process inappropriate for routine analysis
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