Application of capillary electrophoresis to pharmaceutical analysis

Tsai, Eric W.; Singh, Manohar M.; Lu, Hannah; Ip, Dominic P.; Brooks, Marvin A.

doi:10.1016/0021-9673(92)85416-q

Cited by 51 publications

(11 citation statements)

References 29 publications

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“…In this context, CE‐based methodologies might serve as useful alternatives for ALN quantitation, due to their high resolution, short analysis times, low sample and solvent consumption and adequate sensitivity. Few works have been reported about the use of CE for ALN determination, based either on indirect UV‐detection or direct UV‐detection after the formation of an ALN complex inside the capillary column or after a previous derivatization of ALN with naphthalene‐2,3‐dicarboxaldehyde (NDA) for fluorescence detection . To date, there have been no reports in the literature regarding either ALN quantification from complex drug delivery matrices such as the ones describes above or about CE‐methods based on ALN derivatization with OPA and 2‐ME for direct UV‐detection.…”

Section: Methods Validation For the Cze‐uv Assay For The Determinationmentioning

confidence: 99%

Development and validation of a novel sensitive UV‐direct capillary electrophoresis method for quantification of alendronate in release studies from biomaterials

2017

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A simple, highly sensitive, and robust CE method applied to the determination of alendronate (ALN) was developed from matrices for tissue engineering, characterized by being highly complex systems. The novel method was based on the ALN derivatization with o-phthalaldehyde and 2-mercaptoethanol for direct ultraviolet detection at 254 nm. The BGE consisted of 20 mM sodium borate buffer at pH 10, and the electrophoretic parameters were optimized.The method was validated in terms of specificity, linearity, LOD, LOQ, precision, accuracy, and robustness. The LOD and LOQ obtained were 0.8 and 2.7 μg/mL, respectively. In addition, the method offers higher sensitivity and specificity compared to other CE and HPLC methods using UV-detectors, as well as low cost and simplicity that allowed the rapid and simple quantitation of ALN from bone regeneration matrices.

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Section: Methods Validation For the Cze‐uv Assay For The Determinationmentioning

confidence: 99%

Development and validation of a novel sensitive UV‐direct capillary electrophoresis method for quantification of alendronate in release studies from biomaterials

2017

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“…A water solution of nitric acid was tried as an eluent following the literature data [24][25][26][27]. First, it was tried with the concentration of 7 mM HNO 3 without addition of any organic modificator in mobile phase, using isocratic flow.…”

Section: Methods Developmentmentioning

confidence: 99%

“…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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Application of capillary electrophoresis to pharmaceutical analysis

Cited by 51 publications

References 29 publications

Development and validation of a novel sensitive UV‐direct capillary electrophoresis method for quantification of alendronate in release studies from biomaterials

Development and validation of a novel sensitive UV‐direct capillary electrophoresis method for quantification of alendronate in release studies from biomaterials

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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