Comparison between liquid chromatography–UV detection and liquid chromatography–mass spectrometry for the characterization of impurities and/or degradants present in trimethoprim tablets

Barbarin, Nicolas; Henion, Jack D.; Wu, Yunhui

doi:10.1016/s0021-9673(02)01035-x

Cited by 31 publications

(15 citation statements)

References 14 publications

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“…A comparison between LC/UV and LC/MS for characterization of impurities and degradation products in trimethoprim tablets has been shown (Barbarin, Henion, & Wu, 2002). This work showed that MS is well suited for detection and characterization of impurities and degradation products present in drug formulations.…”

Section: Pharmaceutical Product Developmentmentioning

confidence: 84%

Mass spectrometry for small molecule pharmaceutical product development: A review

Gillespie

Winger

2010

Mass Spectrometry Reviews

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Developing a pharmaceutical product has become increasingly difficult and expensive. With an emphasis on developing project knowledge at an earlier stage in development, the use of information-rich technologies (particularly MS) has continued to expand throughout product development. Continued improvements in LC/MS technology have widened the scope of utilizing MS methods for performing both qualitative and quantitative applications within product development. This review describes a multi-tiered MS strategy designed to enhance and accelerate the identification and profiling of both process- and degradation-related impurities in either the active pharmaceutical ingredient (API) or formulated product. Such impurities can be formed either during chemical synthesis, formulation, or during storage. This review provides an overview of a variety of orthogonal-mass spectrometric methodologies, namely GC/MS, LC/MS, and ICP-MS, in support of product development. This review is not meant to be all inclusive; however, it has been written to highlight the increasing use of hyphenated MS techniques within the pharmaceutical development area.

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Section: Pharmaceutical Product Developmentmentioning

confidence: 84%

Mass spectrometry for small molecule pharmaceutical product development: A review

Gillespie

Winger

2010

Mass Spectrometry Reviews

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“…It is sensitive down to the nanogram on five orders of magnitude linear range, up to almost a milligram injected. With optimized ionization, the MS detector is known to be almost three orders of magnitude more sensitive than the UV detector [32] . So the MS detector is not compared to the UV detector in term of sensitivity.…”

Section: Resultsmentioning

confidence: 99%

Mass spectrometry detection of basic drugs in fast chiral analyses with vancomycin stationary phases

Guo

Wahab

Berthod

et al. 2018

Journal of Pharmaceutical Analysis

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Current trends in chiral analysis of pharmaceutical drugs are focused on faster separations and higher separation efficiencies. Core-shell or superficially porous particles (SPP) based chiral stationary phases (CSPs) provide reduced analysis times while maintaining high column efficiencies and sensitivity. In this study, mobile phase conditions suitable for chiral analyses with electrospray ionization LC-MS were systematically investigated using vancomycin as a representative CSP. The performance of a 2.7 µm SPP based vancomycin CSP (SPP-V) 10 cm × 0.21 cm column was compared to that of a corresponding 5 µm fully porous particles based analogue column. The results demonstrated that the SPP-V column provides higher efficiencies, 2–5 time greater sensitivity and shorter analysis time for a set of 22 basic pharmaceutical drugs. The SPP-V was successfully applied for the analysis of the degradation products of racemic citalopram whose enantiomers could be selectively identified by MS.

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“…The widespread use of HPLC in routine analysis makes it important to develop and thoroughly validate satisfactory HPLC methods [13][14][15][16][17][18][19]. System suitability was evaluated prior to the validation experiments.…”

Section: Resultsmentioning

confidence: 99%

“…Analytical methodologies with high throughput should be considered in the analysis of drugs [10]. The simultaneous determination of the concentrations of both of these compounds generally utilises spectrophotometric methods with multicomponent analysis using a diode-array detector [11,12] and liquid chromatography-HPLC [13][14][15][16][17][18][19]. Kulikov et al (2005) compared micellar liquid chromatography and reverse-phase liquid chromatography and concluded that the techniques present similar efficiency, sensitivity and selectivity for determination of SMX and TMP concentrations [20].…”

Section: Introductionmentioning

confidence: 99%

RP-LC method for simultaneous determination of sulfamethoxazole and trimethoprim content in veterinary drugs

et al. 2016

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This study describes the development of a method for simultaneous analysis of sulfamethoxazole (SMX) and trimethoprim (TMP) through the use of high-performance liquid chromatography/ultraviolet detector, with the application to veterinary medicines. Satisfactory chromatographic separation of SMX and TMP was isocratically with a C18 column (150 x 4.6 mm, 5 mm). A mobile phase consisting of water, pH 3.5, and methanol (60:40, v/v) was delivered at a flow rate of 1.0 mL min-1 for five minutes and then, increased to 1.8 mL min-1. Detection of the drugs was performed at 213 and 230 nm. Linearity was demonstrated in the range of 5 to 70 mg mL-1 for SMX and 1 to 30 mg mL-1 for TMP (r2 ≥ 0.99 for both compounds). The relative standard deviation was ≤ 5%, and the comparison of the results with the concentrations reported on the drug labels indicated that the quantification was accurate. The resultant stressed samples were analysed by the method. The proposed method shows great potential for simultaneous analysis of the drugs evaluated and represents a new alternative approach to quality control of veterinary medicines.

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Comparison between liquid chromatography–UV detection and liquid chromatography–mass spectrometry for the characterization of impurities and/or degradants present in trimethoprim tablets

Cited by 31 publications

References 14 publications

Mass spectrometry for small molecule pharmaceutical product development: A review

Mass spectrometry for small molecule pharmaceutical product development: A review

Mass spectrometry detection of basic drugs in fast chiral analyses with vancomycin stationary phases

RP-LC method for simultaneous determination of sulfamethoxazole and trimethoprim content in veterinary drugs

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