Simultaneous Quantification of Mesalamine and Its Metabolite N-Acetyl Mesalamine in Human Plasma by LC-MS/MS and Its Application to a Bioequivalence Study

Kanala, Kanchanamala; Hwisa, Nagiat T.; Chandu, Babu Rao; Assaleh, Fathi H.; Mukkanti, K.; Katakam, Prakash; Challa, B.R.

doi:10.9734/bjpr/2014/5350

Cited by 7 publications

(3 citation statements)

References 30 publications

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“…The detection limits of both analytes at the CNTs-N/GCE are comparable to chromatographic methods reported previously, moreover, the achieved values are better than those reported for HPLC methods with fluorescence [12] and electrochemical detection [15]. Compared with HPLC method coupled to mass spectrometry [17], the LODs obtained with CNTs-N/GCE for both examined analytes were in a higher concentration range. However, the LOQ values obtained at the CNTs-N/GCE as 6.3 and 16.9 ng/mL for 5-ASA and Ac-5-ASA, respectively, are adequate to quantify concentration levels of 5-ASA and its main metabolite generally found in human plasma samples collected during clinical and pharmacokinetic studies in which delay-released formulations are administered at therapeutic dosage.…”

Section: Comparison With Other Analytical Methodssupporting

confidence: 76%

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Electrochemical sensing of mesalazine and its N-acetylated metabolite in biological samples using functionalized carbon nanotubes

Nigović

Sadiković

Jurić

2016

Talanta

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Section: Comparison With Other Analytical Methodssupporting

confidence: 76%

“…At present, several HPLC methods with a fluorescence [11][12][13], electrochemical [14,15] and mass spectrometry detection [16,17] were developed for simultaneous quantification of 5-ASA and its N-acetylated metabolite. The satisfactory results were obtained with excellent selectivity and low detection limit.…”

Section: Introductionmentioning

confidence: 99%

Electrochemical sensing of mesalazine and its N-acetylated metabolite in biological samples using functionalized carbon nanotubes

Nigović

Sadiković

Jurić

2016

Talanta

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“…[11][12][13][14][15] The drug was also determined by different UV-spectrophotometric, 16) and Vireodt's method. 17) Spectrofluorimetric, 18,19) TLC, 20,21) HPLC, [22][23][24][25] ultra performance liquid chromatography (UPLC) 26,27) and LC-MS 28) were reported for analysis of ME either in single or in combination with other drugs. Only one HPTLC method was published for determination of ME and its degradation products that depended on using toluene-methanol-ethyl acetate (6.5 : 2.5 : 1, v/v/v) as a developing system and scanning at 244 nm.…”

mentioning

confidence: 99%

Different Spectrophotometric and TLC-Densitometric Methods for Determination of Mesalazine in Presence of Its Two Toxic Impurities

Morcoss

Abdelwahab

Ali

et al. 2016

CHEMICAL & PHARMACEUTICAL BULLETIN

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Two selective spectrophotometric and TLC-densitometric methods were developed for determination of mesalazine (ME) and its two toxic impurities, 4-amino phenol (4AP) and salicylic acid (SA) without preliminary separation. The proposed methods are: ratio difference in the subtracted spectra (RDSS) {Method 1}, area under the curve (AUC) {Method 2} and TLC-densitometric {Method 3}. In method {1} combination of measuring the amplitude of the constant at 350 nm (using standard spectrum of 10 µg/mL ME as a divisor) and ratio difference in the subtracted ratio spectrum for determination of 4AP and SA using the ratio difference at 221.4 and 242.2 nm, 230 and 241.2 nm, respectively. In method {2} ME was determined by direct measuring the AUC in the wavelength range of 350-370 nm while the impurities could be determined by dividing their spectra by standard spectrum of 10 µg/mL ME then interference from ME was eliminated by subtracting the amplitude of the constant at 350 nm then multiplying by the divisor. AUC in the range of 220-230 and 235-245 nm was used for measuring concentrations of 4AP and SA. On the other hand, the third method {3} is TLC-densitometric method at which chromatographic separation was achieved using ethyl acetate-methanol-triethylamine (8.5 : 2 : 0.7, v/v/v) as a developing system with UV scanning at 230 nm. The validation of the proposed methods was performed according to International Conference on Harmonization (ICH) guidelines. No significant difference was found when these methods were compared to the reported one.

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Estimation of Mesalamine in Human Plasma Using Rapid and Sensitive LC-ESI-MS/MS Method

Pathan

Kshirsagar

2021

Pharm Chem J

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A sensitive, selective and rapid liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) method has been developed for the estimation of mesalamine in human plasma using a derivatization technique. A liquid-liquid extraction technique with ethyl acetate was used for the extraction of mesalamine and mesalamine-D3 internal standard (IS). Mesalamine and mesalamine-D3 were analyzed on Thermo BetaBasic C8 (100 mm ´4.6 mm, 5 mm) column using acetonitrile and 10 mM ammonium formate in 70 : 30 v/v ratio under isocratic elution mode. The MS detection and quantitation were performed under multiple reaction monitoring using positive ESI for mesalamine (m/z, 210.1 ® 191.9) and mesalamine D3 (m/z, 213.2 ® 195.1). Main advantages of the proposed method include higher sensitivity (5.00 ng/mL), superior extraction efficiency (³79%), and small volume (200 mL) of sample for processing. The calibration curve was linear in the concentration range of 5.00 -2957.17 ng/mL with a good correlation coefficient (r 2 ³ 0.9980) for mesalamine. The intra-batch (within day) and inter-batch (between days) precision (% CV) and accuracy (% nominal) values varied from 2.09 to 4.44% and from 96.02 to 103.23%, respectively. The method was validated as per the US FDA guidelines and the results were found accurate and precise.

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Simultaneous Quantification of Mesalamine and Its Metabolite N-Acetyl Mesalamine in Human Plasma by LC-MS/MS and Its Application to a Bioequivalence Study

Cited by 7 publications

References 30 publications

Electrochemical sensing of mesalazine and its N-acetylated metabolite in biological samples using functionalized carbon nanotubes

Electrochemical sensing of mesalazine and its N-acetylated metabolite in biological samples using functionalized carbon nanotubes

Different Spectrophotometric and TLC-Densitometric Methods for Determination of Mesalazine in Presence of Its Two Toxic Impurities

Estimation of Mesalamine in Human Plasma Using Rapid and Sensitive LC-ESI-MS/MS Method

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