A novel RP-HPLC method development and validation for determination and estimation of eluxadoline drug with its impurities

Pakalapati, Srinivasarao; Rumalla, Chidananda Swamy; Gudapati, Atchyut Ramakrishna; Korupolu, Raghu Babu; Gajbhiye, Susheela Bai; Kaliyaperumal, Muralidharan

doi:10.1007/s42452-020-2834-9

Cited by 8 publications

(5 citation statements)

References 12 publications

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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%

“…The LC-MS/MS technique was used to investigate the pharmacokinetics of eluxadoline in healthy South Indian male participants [11]. 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].…”

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%

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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“…There were no further peaks that were seen when they were investigated. It was discovered that there is a very high resolution between Impurity 2 and the drug, as well as between the drug and Impurity 1 [40].…”

Section: Identification Of the Impuritymentioning

confidence: 99%

Advances of hyphenated technique in impurity profiling of active pharmaceutical ingredients and pharmaceutical products

Khandale,

Rajge,

Singh

et al. 2023

Separation Science Plus

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Impurities found in active pharmaceutical ingredients (APIs) and pharmaceutical products are of ever‐increasing interest. According to several regulatory agencies, purity and impurity profiles are essential. An impurity is defined as any additional inorganic or organic material, residual solvents other than the medicinal components, or undesired compounds that remain with APIs. Impurities and degradation products in bulk drug materials and pharmaceutical formulations are identified, their structures are clarified, and their quantitative determination is part of impurity profiling. Unrecognized, poisonous impurities are dangerous to health and should be identified by selective procedures to increase the safety of drug therapy, and impurity profiling has become more significant in pharmaceutical analysis. This review briefly introduces process and product‐related impurities and emphasizes the creation of cutting‐edge analytical techniques for identifying them. It discusses the use of analytical methods, particularly high‐performance thin‐layer chromatography, liquid chromatography with mass spectrometry (MS), ultrahigh‐performance liquid chromatography, gas chromatography–MS, and nuclear magnetic resonance spectroscopy for the identification of contaminants and degradation products. It has discussed the importance of the quality, efficacy, and safety of drug substances and products, including the origin, types, and quality control of impurities, the need for the development of impurity profiling methods, impurity identification, and regulatory aspects.

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“…RP-HPLC method for quantitative determination of eluxadoline in presence of its impurities was described. 11 HPLC-PDA for simultaneous estimation of eluxadoline along with rifaximin in plasma of rat was reported. 12 There is no HPLC method reported for the estimation of eluxadoline in presence of its forced degradation products.…”

Section: Introductionmentioning

confidence: 99%

A New Stability Indicating HPLC-PDA Method for Estimation of Eluxadoline in Presence of its Degradation Products

Patil¹,

Basuri²,

Desai³

2023

Ind. J. Pharm. Edu. Res

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Background:The goal of proposed study was to optimize and validate reversed phase high performance liquid chromatography (RP-HPLC) method for assessment of eluxadoline in presence of its forced degradation products in in-house tablet mixture. Materials and Methods: RP-HPLC method was developed using SunQSil C 18 (250 mm × 4.6 mm, 5 µm) as stationary phase and 20 mM sodium acetate: methanol (45:55, v/v) as mobile phase at a 1 ml/min flow rate with 205 nm detection wavelength. The method was found to give a resolved peak of eluxadoline at retention time of 5.32 min. To study degradation behaviour of eluxadoline, it was exposed to acid hydrolysis, alkali hydrolysis, oxidation, photolysis and thermolysis. The developed method was suitable to resolve eluxadoline from its all-degradation products. Validation of method was carried out in accoradance with ICH quality guideline Q2(R1). Results: In the concentration range of 3 -18 µg/ml, the linearity of the proposed process was observed with regression coefficient (R 2 ) of 0.9987. Sensitivity parameters, LOD and LOQ were observed to be 0.8627 µg/ml and 2.6144 µg/ml, respectively. In accuracy studies, the recovery of the drug was found to be between 99.1956-100.7294%. It was noticed that the developed was precise as the values of % RSD were found to be less than 2.0 % for both intraday and interday precision. The method was robust and can be useful for regular analysis of formulations containing eluxadoline. Conclusion: The developed method was utilised for determination of content of eluxadoline in in-house tablet mixture.

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A novel RP-HPLC method development and validation for determination and estimation of eluxadoline drug with its impurities

Cited by 8 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

Advances of hyphenated technique in impurity profiling of active pharmaceutical ingredients and pharmaceutical products

A New Stability Indicating HPLC-PDA Method for Estimation of Eluxadoline in Presence of its Degradation Products

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