Degradation behavior of eluxadoline under stress conditions: Structural interpretation of novel degradants using high resolution mass spectrometry and nuclear magnetic resonance

Vajjha, Soujanya; Bommuluri, Vijay; Rumalla, Chidananda Swamy; Kaliyaperumal, Muralidharan; Korupolu, Raghu Babu; chopella, Vidyasagar

doi:10.1016/j.matpr.2020.02.135

Cited by 2 publications

(3 citation statements)

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“…From the literature reports, no analytical approach for the simultaneous determination of eluxadoline and rifaximin in rat plasma has been described. Currently, there are few literature reports on the methods for the individual determination of eluxadoline have been reported [10][11][12][13] and for the individual estimation of rifaximin have been reported [14][15][16][17][18][19][20]. Even though these techniques have attained the requisite sensitivity and application, some of them require a considerable volume of plasma, many Whereas, the method used in the present study, HPLC-PDA has numerous advantages such as good separation, high sensitivity, outstanding specificity, and low cost as compared to the methods reported earlier.…”

Section: Discussionmentioning

confidence: 99%

“…In 2015, FDA approved Rifaximin (RFX) for the treatment of the gastrointestinal disorder (IBS-D) in adults. It is chemically designated as (2S,16Z,18E,20S,21S,22R,23-R,24R,25S,26R,27S,28E)-25-(Acetyloxy)-5,6,21,23-tetra hydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca [1,11,13]trienimino)benzofuro [4,5e]pyrido [1,2-a]benzimidazole-1,15(2H)-dione.…”

Section: Introductionmentioning

confidence: 99%

“…RP-HPLC was used to separate and identify eluxadoline and its impurities [12]. The degradation behaviour of the eluxadoline under various stress conditions followed by the identification of the degradation products by HR-MS/MS and NMR studies was reported [13]. Similarly, to determine RFX in biological matrices and pharmaceutical dosage forms, various analytical methods such as HPLC [14][15][16][17], LC-MS/MS [18], LC-ESI-MS [19,20] have been reported.…”

Section: Introductionmentioning

confidence: 99%

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Validation of the HPLC–PDA method for detection of eluxadoline and rifaximin in rat plasma and application in a pharmacokinetic study

et al. 2022

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Background A precise, simple, accurate, and quick HPLC–PDA method for the determination of eluxadoline and rifaximin in rat plasma was developed and validated in this study. In this method, Loperamide hydrochloride was used as the internal standard and plasma samples were prepared using a liquid–liquid extraction technique for which acetonitrile was a solvent. An Agilent Symmetry C8 column (5 µm, 250 mm × 4.6 mm) at 283 nm and isocratic elution using HPLC grade acetonitrile and 7 mM TEA (pH 2.5) with a ratio of (40: 60 v/v) was used as a mobile phase and the flow rate employed was 1 mL min−1. A satisfactory chromatographic separation was accomplished. Results An HPLC–PDA method for the determination of eluxadoline and rifaximin with retention times of 3.06 and 7.82 min, respectively, was developed. The calibration curves appear linear for both eluxadoline and rifaximin in the range of 5–200 ng mL−1 and 10–400 ng mL−1, and the corresponding correlation coefficient values were found to be 0.9999 and 0.9998 respectively. Lower limits of quantification (LLOQ) for eluxadoline and rifaximin were evaluated to be 5.0 ng mL−1 and 10.0 ng mL−1, respectively. The accuracy and precision results in all validation experiments were within the acceptance limits of FDA guidelines. Conclusion The developed HPLC–PDA approach was fully validated to meet the USFDA guidelines for bioanalytical method validation in terms of precision, accuracy, and stability. The presented approach could be beneficial for the determination of ELX and RFX in rat plasma, according to validation parameters. This is one of the efficient method to study the pharmacokinetics of ELX and RFX in rats. Graphical abstract

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Validation of the HPLC–PDA method for detection of eluxadoline and rifaximin in rat plasma and application in a pharmacokinetic study

et al. 2022

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An Inclusive Exploration of Forced Degradation Analysis of Some Therapeutic Categories of Drugs in the Last Decade

Narsinghani¹,

Tuteja²,

Singh³

2023

Journal of the Scientific Society

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In the pharmaceutical industry, forced degradation tests are used to assess the stability of drug samples. Examining degradation products under stress is beneficial for determining degradation pathways as well as designing and validating appropriate analytical techniques. Forced degradation experiments reveal the molecule’s chemical behavior, which aids formulation and packaging creation. The current review examines the forced degradation of a variety of therapeutic classes of medications, including anticancer, antihypertensive, antiviral, CNS pharmaceuticals, and other miscellaneous drugs. During forced degradation analysis, the study examines the degradation behavior of several medications from the abovementioned categories. The findings will likely aid researchers in determining the degradation process of related drugs belonging to the same category.

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Degradation behavior of eluxadoline under stress conditions: Structural interpretation of novel degradants using high resolution mass spectrometry and nuclear magnetic resonance

Cited by 2 publications

References 12 publications

Validation of the HPLC–PDA method for detection of eluxadoline and rifaximin in rat plasma and application in a pharmacokinetic study

Validation of the HPLC–PDA method for detection of eluxadoline and rifaximin in rat plasma and application in a pharmacokinetic study

An Inclusive Exploration of Forced Degradation Analysis of Some Therapeutic Categories of Drugs in the Last Decade

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