Separation and identification of moxifloxacin impurities in drug substance by high-performance liquid chromatography coupled with ultraviolet detection and Fourier transform ion cyclotron resonance mass spectrometry

Wu, Cai Sheng; Jia, Zhu; Ning, Bao Ming; Zhang, Jin Lan; Wu, Song

doi:10.1016/j.cclet.2012.09.001

Cited by 9 publications

(2 citation statements)

References 4 publications

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“…Also, most reported HPLC methods for determination of moxifloxacin and its impurities use a high percentage of organic solvents (methanol or acetonitrile) in the mobile phase which cannot be considered as environmentally friendly solvents. [4][5][6][7][8][9][10][11] Micellar liquid chromatography (MLC) method has been investigated as an interesting approach for green analytical chemistry (GAC), as it eliminates or reduces the use of organic solvents and uses mobile phases containing 90% (v/v) or more water. [12][13][14][15][16][17] MLC is attractive due to its lower cost, lower toxicity, greater stability, reduced negative impact on the environment and greater safety for laboratory use.…”

Section: Introductionmentioning

confidence: 99%

Micellar Liquid Chromatographic Method for Determination of Moxifloxacin and its Impurities

Salkić,

Otašević,

Rašević

et al. 2023

ACSi

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A selective eco-friendly micellar HPLC method was developed for investigation of moxifloxacin and related compounds in the presence of its degradation products. Central composite design was used to optimize the experimental conditions. The proposed method is based on isocratic elution on a C18 column using 92.5% (v/v) biodegradable aqueous mobile phase containing 0.01 M sodium dihydrogen phosphate, 0.15 M sodium dodecyl sulfate (SDS) and 0.5% triethylamine (v/v) with a pH of 3.5 and 7.5% isopropanol (v/v) as eco- friendly organic solvent. The flow rate and injection volume were 0.6 ml/min and 5 μl, respectively. Experiments were performed at a temperature of 60 °C and detection was performed at 295 nm. The optimized method was validated. The method was found to be suitable for the quantification of moxifloxacin and its related compounds in moxifloxacin drug substance. The Green Analytical Procedure Index (GAPI) proves the superiority of the developed method against other reported methods.

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Section: Introductionmentioning

confidence: 99%

Micellar Liquid Chromatographic Method for Determination of Moxifloxacin and its Impurities

Salkić,

Otašević,

Rašević

et al. 2023

ACSi

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show abstract

“…A number of stability‐indicating HPLC methods for the analysis of moxifloxacin (Attimarad et al, 2019; Lalitha Devi & Chandrasekhar, 2009; Momin et al, 2018; Predrag et al, 2009; Razzaq et al, 2014; Syed Naeem et al, 2012; Van Doorslaer et al, 2012; Wu et al, 2012) reported in the literature followed good chromatographic integration practices as per USP <621> general chapter. Different combination formulations were reported in the literature.…”

Section: Introductionmentioning

confidence: 99%

A rapid RP‐HPLC stability‐indicating method development and validation of moxifloxacin hydrochloride–related substances in finished dosage forms

Vankalapati

Algete

Boodida

2021

Biomedical Chromatography

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A reversed‐phase high‐performance liquid chromatography (RP‐HPLC) method was developed and validated for the identification and quantification of moxifloxacin hydrochloride–related substances in finished dosage forms. Chromatographic separation was achieved on an Agilent C18 column (150 × 4.6 mm, 5 μm) with the mobile phase (0.01 M potassium dihydrogen orthophosphate as buffer and methanol in the ratio of 70:30) eluted in isocratic mode. The HPLC flow rate was 1.0 mL min−1, and peaks were monitored at 230 nm using a photodiode array (PDA) detector. The column temperature was kept constant at 30°C, and the injection volume was 10 μL. The run time of the method was 16 min. The method was validated as per the International Conference on Harmonization (ICH) guidelines. Linearity was recorded at various concentrations ranging from 0.25 to 1.5 μg mL−1 for all the moxifloxacin impurities. Linearity, regression value, recovery, %relative standard deviation (RSD) of method precision values were found within the acceptance limits. The method for related substances (RS) in moxifloxacin was found to be specific, linear, accurate, precise, rugged, and robust. The validated method was suitable for the quantification of the RSs in moxifloxacin drug products. The method was applied in quality control lab for the analysis of moxifloxacin impurities in stability analysis.

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Moxifloxacin Hydrochloride

Omari

Jaafari

Al-Sou’od

et al. 2014

Profiles of Drug Substances, Excipients and Related Methodology

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Separation and identification of moxifloxacin impurities in drug substance by high-performance liquid chromatography coupled with ultraviolet detection and Fourier transform ion cyclotron resonance mass spectrometry

Cited by 9 publications

References 4 publications

Micellar Liquid Chromatographic Method for Determination of Moxifloxacin and its Impurities

Micellar Liquid Chromatographic Method for Determination of Moxifloxacin and its Impurities

A rapid RP‐HPLC stability‐indicating method development and validation of moxifloxacin hydrochloride–related substances in finished dosage forms

Moxifloxacin Hydrochloride

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