Simultaneous Determination of EDTA, Sorbic Acid, and Diclofenac Sodium in Pharmaceutical Preparations Using High-Performance Liquid Chromatography

Heydari, Rouhollah; Shamsipur, Mojtaba; Naleini, Nasim

doi:10.1208/s12249-013-9962-0

Cited by 14 publications

(17 citation statements)

References 29 publications

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“…The determination of EDTA by ion-pairing HPLC using metallocomplexes has been known for some time [4] , [6] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] . In addition, the determination of EDTA in pharmaceutical formulations based on HPLC has been reported [5] , [20] , [21] , [23] . The use of metallocomplexes with ion-pairing chromatography introduces additional variables that require greater investigation during method development.…”

Section: Resultsmentioning

confidence: 99%

“…Laamanen et al [14] reported simultaneous determination of DTPA, EDTA and NTA by a CE/UV method using copper (II) complexation. A number of articles reported determination of trace level of APCAs in natural water, food and environmental samples by using ion-pairing reversed-phase HPLC coupled with UV-visible detector for quantitation of APCA metellocomplexes [4] , [6] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] .…”

Section: Introductionmentioning

confidence: 99%

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Ion-pairing HPLC methods to determine EDTA and DTPA in small molecule and biological pharmaceutical formulations

Wang

Tomasella

2016

Journal of Pharmaceutical Analysis

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Ion-pairing high-performance liquid chromatography–ultraviolet (HPLC–UV) methods were developed to determine two commonly used chelating agents, ethylenediaminetetraacetic acid (EDTA) in Abilify® (a small molecule drug with aripiprazole as the active pharmaceutical ingredient) oral solution and diethylenetriaminepentaacetic acid (DTPA) in Yervoy® (a monoclonal antibody drug with ipilimumab as the active pharmaceutical ingredient) intravenous formulation. Since the analytes, EDTA and DTPA, do not contain chromophores, transition metal ions (Cu2+, Fe3+) which generate highly stable metallocomplexes with the chelating agents were added into the sample preparation to enhance UV detection. The use of metallocomplexes with ion-pairing chromatography provides the ability to achieve the desired sensitivity and selectivity in the development of the method. Specifically, the sample preparation involving metallocomplex formation allowed sensitive UV detection. Copper was utilized for the determination of EDTA and iron was utilized for the determination of DTPA. In the case of EDTA, a gradient mobile phase separated the components of the formulation from the analyte. In the method for DTPA, the active drug substance, ipilimumab, was eluted in the void. In addition, the optimization of the concentration of the ion-pairing reagent was discussed as a means of enhancing the retention of the aminopolycarboxylic acids (APCAs) including EDTA and DTPA and the specificity of the method. The analytical method development was designed based on the chromatographic properties of the analytes, the nature of the sample matrix and the intended purpose of the method. Validation data were presented for the two methods. Finally, both methods were successfully utilized in determining the fate of the chelates.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Ion-pairing HPLC methods to determine EDTA and DTPA in small molecule and biological pharmaceutical formulations

Wang

Tomasella

2016

Journal of Pharmaceutical Analysis

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“…[5][6][7] Hence, diclofenac sodium and moxifloxacin ophthalmic solutions are used simultaneously after the cataract surgery. Several analytical methods such as spectrophotometry, [8][9][10][11][12] RP-HPLC [13][14][15][16][17][18][19][20][21][22][23] and electroanalytical methods [24][25][26] were reported in the literature for the quantification of DCL and MOX alone or with other drugs. However, the simultaneous determination of DCL and MOX has not been reported.…”

Section: Introductionmentioning

confidence: 99%

Eco-friendly Derivative UV Spectrophotometric Methods for Simultaneous Determination of Diclofenac Sodium and Moxifloxacin in Laboratory Mixed Ophthalmic Preparation

Chohan¹,

Elgorashe²,

Balgoname³

et al. 2019

IJPER

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Background: Diclofenac Sodium (DCL) and Moxifloxacin HCl (MOX) were simultaneously used after cataract surgery to reduce the post-operative inflammation and to control infection respectively. Objectives: Three simple, accurate, eco-friendly and reproducible UV spectroscopic methods were established for concurrent determination of diclofenac sodium and moxifloxacin in ophthalmic preparation without prior separation. Methods: The first technique was established on the measurement of a peak amplitude of the first derivative spectra at the zero-crossing wavelength of one analyte. The second method was the determination of peak amplitude difference between peak and trough of ratio spectra. The third method involves the measurement of the peak amplitude of the first derivative of ratio spectra. Water has been used as a solvent. Results: The analytes exhibited good linearity in the range of 1-15 µg/mL for DCL and 1-18 µg/mL for MOX with excellent correlation coefficient (r 2 >0.999). Low percent relative standard deviation confirmed the precision of the methods. Excellent recovery with low percent relative error proved the accuracy of the methods. The specificity of the methods was evaluated by analyzing the laboratory prepared solutions of DCL and MOX. Conclusion: Proposed three techniques were effectively utilized for the simultaneous determination of DCL and MOX from ophthalmic preparation. The outcomes of the proposed procedures were compared with the earlier described methods and no statistical difference was found between the methods in terms of accuracy and precision.

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“…Heydari et al. developed a HPLC method for the simultaneous separation and quantitation of EDTA, sorbic acid, and diclofenac in ophthalmic solutions. Krasikovet al.…”

Section: Introductionmentioning

confidence: 99%

“…HPLC has proven to be effective in separating and detecting various analytes [15][16][17]. Heydari et al [18] developed a HPLC method for the simultaneous separation and quantitation of EDTA, sorbic acid, and diclofenac in ophthalmic solutions. Krasikovet al [19] used HPLC-TLC to investigate the influence of molecular and structural characteristics of polyamic acids (PAAs) on their ability to form metal-polymer complexes with copper (I) chloride.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous separation and determination of seven chelating agents using high‐performance liquid chromatography based on statistics design

Liu

Chen

2019

J of Separation Science

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We describe an optimization approach to determine simultaneously occurring chelating agents (glycine, malonic acid, citric acid, glycolic acid, lactic acid, DL‐malic acid, and ethylenediaminetetraacetic acid) in an electroplating effluent using high‐performance liquid chromatography. With chromatography signal area and overall resolution considered as responses, detection conditions were optimized via multiple functions combined with response surface methodology and Plackett–Burman design. Optimized detection conditions were as follows: 15 mmol/L ammonium phosphate buffer (pH 2.5), a 94:6 v/v ratio of ammonium phosphate buffer/acetonitrile, a column temperature of 23.3°C, and a mobile phase flow rate of 1 mL/min. The experimental values conformed to the predicted values and were repeatable (relative standard deviation < 6.4%) and linear (r2 > 0.991) over concentration ranges of 1–100 µmol/L. Moreover, the quantification limit (signal‐to‐noise ratio = 10) and the detection limit (signal‐to‐noise ratio = 3) ranged from 0.03 to 0.15 µmol/L and from 0.01 to 0.04 µmol/L, respectively. These results indicate that high‐performance liquid chromatography coupled with statistical design may be a simple and rapid method for simultaneously determining multiple chelating agents in electroplating wastewater effectively.

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Simultaneous Determination of EDTA, Sorbic Acid, and Diclofenac Sodium in Pharmaceutical Preparations Using High-Performance Liquid Chromatography

Cited by 14 publications

References 29 publications

Ion-pairing HPLC methods to determine EDTA and DTPA in small molecule and biological pharmaceutical formulations

Ion-pairing HPLC methods to determine EDTA and DTPA in small molecule and biological pharmaceutical formulations

Eco-friendly Derivative UV Spectrophotometric Methods for Simultaneous Determination of Diclofenac Sodium and Moxifloxacin in Laboratory Mixed Ophthalmic Preparation

Simultaneous separation and determination of seven chelating agents using high‐performance liquid chromatography based on statistics design

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