Development and application of a high-performance liquid chromatography–mass spectrometry method to determine alendronate in human urine

Tarcomnicu, Isabela; Silvestro, Luigi; Savu, Simona Rizea; Gherase, Adriana; Dulea, Constanta

doi:10.1016/j.chroma.2007.04.020

Cited by 39 publications

(32 citation statements)

References 7 publications

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“…A fused-silica capillary column HP-1 (5m x 0.53 mm i.d., 2.65μm film thickness) was used and flame photometric detection. The same reaction was later used by our group directly on biological samples (urine); this reduced the polarity of the molecule and allowed the extraction with organic solvent (Tarcomnicu et al, 2007). An interesting reaction described by Kline et al (1992) uses 2,3 naphtalenedicarboxaldehyde, in presence of cyanide ions as nucleophiles.…”

Section: Hplc Analysis Of Bisphosphonatesmentioning

confidence: 99%

“…When the reagent was TMOF, an increase of 28 mass units was observed; for TMOA and TEOA the shift was 42, and for TMOB 70 Da. Based on these results, we have further developed a double derivatization method for the quantification of alendronate in urine by LC-MS/MS (Tarcomnicu et al, 2007). First, the amino group was reacted with isobutyl chloroformate (IBCF), to facilitate the extraction of the polar drug from biological matrix with organic solvent.…”

Section: Overview On Mass Spectrometric Analysis Of Biphosphonatesmentioning

confidence: 99%

“…A high-throughput method with an LLOQ of 200 pg/mL was optimized and fully validated according to FDA guidelines. Owing to its structure (N-substituted aminobisphosphonate), ibandronate was isolated from plasma extracts with the same technique previously proposed for alendronate (Tarcomnicu et al, 2007). To reduce the polarity of the molecule and make it suitable for reversed-phase LC, in the next step we decided to methylate the phosphonic groups.…”

Section: Overview On Mass Spectrometric Analysis Of Biphosphonatesmentioning

confidence: 99%

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HPLC-MS/MS of Highly Polar Compounds

Silvestro¹,

Tarcomnicu²,

Savu³

2012

Tandem Mass Spectrometry - Applications and Principles

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Section: Hplc Analysis Of Bisphosphonatesmentioning

confidence: 99%

Section: Overview On Mass Spectrometric Analysis Of Biphosphonatesmentioning

confidence: 99%

Section: Overview On Mass Spectrometric Analysis Of Biphosphonatesmentioning

confidence: 99%

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HPLC-MS/MS of Highly Polar Compounds

Silvestro¹,

Tarcomnicu²,

Savu³

2012

Tandem Mass Spectrometry - Applications and Principles

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“…Bisphosphonates have been analyzed in pharmaceutical forms [16,17] and human plasma [18,19] using UV spectrophotometry [20,21], RP-HPLC with UV detection [22,23], fluorimetric detection [24] ion chromatography [25], capillary electrophoresis [26,27], LC-MS [28] and LC-MS 2 [29].…”

Section: Introductionmentioning

confidence: 99%

Chemometric-assisted determination of some bisphosphonates and their related substances in pharmaceutical forms by ion chromatography with inverse UV detection

Zirojević

Jovic

Djurdjevic

et al. 2015

Acta Chromatographica

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Summary.A simple ion chromatographic (IC) method was developed and validated for simultaneous or individual determination of zoledronic, alendronic, pamidronic acids and their related substances in pharmaceutical formulation. The analytes were separated on Waters IC-Pak Anion HR analytical column with a nitric acid (3 mM) without any other additives, as mobile phase at a flow rate of 1.0 mL min −1 . Inverse UV detection was used at 240 nm. Important chromatographic factors that influence the chromatography responses were screened by 11/12 Pluckett-Burman design and their interaction were assayed by 2 3 full factorial design. The RP-HPLC method was optimized with the aid of LC-Simulator ® (ACD Labs, Toronto, Ontario, Canada) software. Validated method was successfully used for quantitative analysis of PAMIFOS ® , concentrate for infusion (Habitfarm AD, Ivanjica, Serbia), ZOMETA ® , powder for infusion (Novartis Pharma, Stein AG, Switzerland) and BONAP ® tablets (Hemofarm, Vrsac, Serbia). Total chromatographic analysis time per sample was approximately 6 min, which represents significant improvement over existing methods. Validation studies revealed that the method is specific, rapid, reliable, and reproducible. Calibration plots were linear over the concentration ranges 20-120 μg mL −1 and 0.1-2 μg mL −1 for bisphosponates and their related substances, respectively. The LODs were 8.7, 4.7, 2.5, 0.026 and 0.011 μg mL −1 for alendronate, pamidronate, zoledronate, phosphoric acid and phosphorous acid, respectively.

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“…Therefore, with recent improvement in the sensitivity of alendronate analytical assay, several research studies have attempted to optimize analysis of alendronate from plasma samples. A number of methods for the determination of alendronate in biological fluids have been published (Tsai et al, 1992;Usui et al, 1992Usui et al, , 1994Niemi et al, 1997;Sparidans and den Hartigh, 1999;Mönkkönen et al, 2000;Zhu et al, 2006;Tarcomnicu et al, 2007). Among these methods, high-performance liquid chromatography (HPLC) is a conventional technique that is readily used to detect alendronate in biological fluids.…”

Section: Introductionmentioning

confidence: 99%

Determination of alendronate in low volumes of plasma by column-switching high-performance liquid chromatography method and its application to pharmacokinetic studies in human plasma

Ban

Park²,

Kim

et al. 2011

Arch. Pharm. Res.

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A sensitive and simple column-switching high-performance liquid chromatographic (HPLC) method with fluorescence detection was developed for the determination of alendronate in human plasma. Alendronate and pamidronate (internal standard, IS) in plasma including Na(2)EDTA were precipitated with sodium hydroxide and calcium chloride after deproteinization using 10% trichloroacetic acid solution. The precipitated alendronate and IS were reconstituted by sodium citrate and citric acid and then derivatized with 9-fluorenylmethyl chloroformate. The resulting solution was injected onto an HPLC system consisting of a pretreatment column and an analytical column, which were connected with a six-port switching valve. The assay was linear in the concentration range of 2-100 ng/mL in 1 mL of plasma with high precision and accuracy, and the limit of detection was 0.5 ng/mL. It was successfully applied to evaluate the pharmacokinetic parameters of alendronate in human volunteers following single oral administration. The mean value of maximum alendronate plasma concentration (C(max)) was 37.69 ng/mL, and the mean time to reach the C(max) (T(max)) was 1.08 h. The area under the plasma concentration-time curve (AUC) and elimination half-life (T(1/2)) were 106.48 ng/mL/h and 1.66 h, respectively.

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Development and application of a high-performance liquid chromatography–mass spectrometry method to determine alendronate in human urine

Cited by 39 publications

References 7 publications

HPLC-MS/MS of Highly Polar Compounds

HPLC-MS/MS of Highly Polar Compounds

Chemometric-assisted determination of some bisphosphonates and their related substances in pharmaceutical forms by ion chromatography with inverse UV detection

Determination of alendronate in low volumes of plasma by column-switching high-performance liquid chromatography method and its application to pharmacokinetic studies in human plasma

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