A Simple HPLC Method for the Separation of Colistimethate Sodium and Colistin Sulphate

Ligai, Bai; Ma, Zhengyue; Yang, Gengliang; Yang, Jian; Cheng, Jialin

doi:10.4172/2157-7064.1000105

Cited by 14 publications

(13 citation statements)

References 11 publications

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“…Other studies using HPLC in tandem with this FTIR method can also prove to be powerful strategies for elucidating the chemistry of this complicated prodrug (36,37). For instance, HPLC separation of methanesulfonated colistin A and B products using a method such as that described by Bai et al (10) followed by FTIR analysis can indicate whether one component is more heavily methanesulfonated. Time course studies may determine whether the methanesulfonate is a more labile leaving group on one component or the other.…”

Section: Discussionmentioning

confidence: 99%

“…High-performance liquid chromatography (HPLC) with UV detection can be used to detect CMS but only at concentrations (0.5 to 5 mg/ml) above those expected in plasma after administration according to current dosing recommendations (9,10). Recently, Nation and colleagues (5,(11)(12)(13) developed an HPLCfluorescence method that enables detection at the physiologically relevant level (0.5 to 30 g/ml) (4,14,15).…”

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Preliminary Method for Direct Quantification of Colistin Methanesulfonate by Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy

Niece

Akers

2015

Antimicrob Agents Chemother

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bColistin use has increased in response to the advent of infections caused by multidrug-resistant organisms. It is administered parenterally as an inactive prodrug, colistin methanesulfonate (CMS). Various formulations of CMS and labeling conventions can lead to confusion about colistin dosing, and questions remain about the pharmacokinetics of CMS. Since CMS does not have strong UV absorbance, current methods employ a laborious process of chemical conversion to colistin followed by precolumn derivatization to detect formed colistin by high-performance liquid chromatography. Here, we report a method for direct quantification of colistin methanesulfonate by attenuated total reflectance Fourier transform infrared spectroscopy (ATR FTIR). Colistin is an antibiotic of the polymyxin family. First available in the 1950s (1), its use diminished by the 1970s due to toxicity concerns and the advent of better-tolerated antibiotics. With the emergence of multidrug-resistant Gram-negative organisms, however, colistin has reappeared in clinical use (1, 2). Colistin is produced naturally by Paenibacillus polymyxa subsp. colistinus and consists of at least 30 separate components. For parenteral administration, it is converted chemically to a sulfonated prodrug, colistin methanesulfonate (CMS) (3). CMS is cleared renally, with a small fraction converted back to the active antibiotic in vivo in humans with healthy kidney function (4). CMS also converts readily to colistin in plasma ex vivo or in acidic aqueous solution (5, 6). Direct measurement of the prodrug in pharmaceutical formulations would reduce existing confusion in dosing regimens, (7,8) and the ability to directly measure the prodrug and the active drug in plasma and tissues is important for better understanding of the metabolic characteristics of colistin. Like colistin, however, CMS is a heterogeneous mixture of molecules due to differing degrees of sulfomethylation, and this heterogeneity combined with weak UV absorbance has hindered the direct measurement of this increasingly used, last-resort antibiotic prodrug.High-performance liquid chromatography (HPLC) with UV detection can be used to detect CMS but only at concentrations (0.5 to 5 mg/ml) above those expected in plasma after administration according to current dosing recommendations (9, 10). Recently, Nation and colleagues (5, 11-13) developed an HPLCfluorescence method that enables detection at the physiologically relevant level (0.5 to 30 g/ml) (4, 14, 15). In this process, CMS is converted to colistin, subsequently derivatized with fluorescent 9-fluorenylmethoxy carbonyl chloride (FMOC-Cl), and then quantified by HPLC with fluorescence detection. If the CMS is already partially converted to colistin, as in a degraded pharmaceutical preparation or a partially metabolized sample, the amount of colistin measured in the fully converted CMS is compared against the amount in the original CMS sample, which must also be derivatized using the same process (12). This method has become widely used and has enabled a n...

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Preliminary Method for Direct Quantification of Colistin Methanesulfonate by Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy

Niece

Akers

2015

Antimicrob Agents Chemother

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“…15 Assay of colistin was conducted via a modified HPLC method originally described by Bai et al 39 with Zorbax SB C-18 column (4.6 Â 150 mm 2 , 3.5 mm; Agilent Technologies) as the stationary phase. The mobile phase consisted of 0.05% (v/v) trifluoroacetic aqueous solution (solvent A) and acetonitrile (solvent B), delivered at 1 mL/min under a linear gradient: 0-8 min, 80%-64% A; 8-10 min, 64% A-80% A. Colistin peak appeared at a retention time of 5.3 min under a UV wavelength of 214 nm.…”

Section: Drug Content Quantificationmentioning

confidence: 99%

Tailored Antibiotic Combination Powders for Inhaled Rotational Antibiotic Therapy

Lee

Teo

Heng

et al. 2016

Journal of Pharmaceutical Sciences

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“…The large number of components in a CMS solution and their rapid hydrolysis means that, to the best of our knowledge, there are no HPLC methods reported that directly quantify CMS. The HPLC methods for CMS that are published are either for the separation of CMS [4] or require the hydrolysis of CMS to colistin, which is then quantitated [3,5,6,7]. The methods of hydrolysing CMS to colistin can be complex and time-consuming and rely on the assumption that all of the CMS components have fully hydrolysed to colistin without the degradation of any of the colistin in the sample during that time period.…”

Section: Introductionmentioning

confidence: 99%

A simple method for assaying colistimethate sodium in pharmaceutical aerosol samples using high performance liquid chromatography

Metcalf

Hardaker

Hatley

2017

Journal of Pharmaceutical and Biomedical Analysis

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A Simple HPLC Method for the Separation of Colistimethate Sodium and Colistin Sulphate

Cited by 14 publications

References 11 publications

Preliminary Method for Direct Quantification of Colistin Methanesulfonate by Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy

Preliminary Method for Direct Quantification of Colistin Methanesulfonate by Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy

Tailored Antibiotic Combination Powders for Inhaled Rotational Antibiotic Therapy

A simple method for assaying colistimethate sodium in pharmaceutical aerosol samples using high performance liquid chromatography

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