Development of an efficient stability‐indicating LC–MS/MS method for the analysis of selexipag and characterization of its degradation products

Babu, Namburi L. A. Amara; Koganti, Kalyani; Palakeeti, Babji; Srinivas, K.; Rao, Koya Prabhakara

doi:10.1002/bmc.5178

Cited by 5 publications

(6 citation statements)

References 15 publications

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“…The animals are housed in similar laboratory conditions with access to endives, carrots and fresh corn (a small amount only). The animal feed should be kept at a temperature of 21–24°C and a humidity of 50–55% (Babu et al, 2021). Before experimentation, all animals were fasted overnight and given water ad libitum .…”

Section: Methodsmentioning

confidence: 99%

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A liquid chromatography–tandem mass spectrometry method development for the quantification of favipiravir drug and its related impurities in rat plasma and its application to pharmacokinetic studies

Koganti,

Amara Babu,

Sattu

et al. 2023

Biomedical Chromatography

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Favipiravir is an antiviral drug used for the treatment of virus‐based diseases such as influenza. In this context, the development of a reliable liquid chromatography–tandem mass spectrometry method for the quantification of the drug and its impurities is necessary, particularly following the COVID‐19 pandemic. Chromatographic separation was achieved on an inertial ODS column using gradient elution with a buffer containing triethylamine in high‐performance liquid chromatography water and adjusting its pH with formic acid. The mixture of buffer and acetonitrile was used as a mobile phase with a flow rate of 1 ml/min at ambient temperature. The separation of favipiravir and its related impurities from remdesivir as an internal standard was achieved. The results indicated that all the variables, like precision, accuracy, linearity, matrix effect and stability, were successfully achieved within the limits of US Food and Drug Administration guidelines. This study could provide a new protocol for the development of new analytical methods for the detection of favipiravir and its impurities.

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Section: Methodsmentioning

confidence: 99%

“…The animal feed should be kept at a temperature of 21-24 C and a humidity of 50-55% (Babu et al, 2021). Before experimentation, all animals were fasted overnight and given water ad libitum.…”

Section: Animal Parametersmentioning

confidence: 99%

A liquid chromatography–tandem mass spectrometry method development for the quantification of favipiravir drug and its related impurities in rat plasma and its application to pharmacokinetic studies

Koganti,

Amara Babu,

Sattu

et al. 2023

Biomedical Chromatography

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“…On 31.12.2021, slexipag is a drug that has been authorized to manage pulmonary arterial hypertension (PAH) to slow the course of the condition and lessen the likelihood of hospitalization due to PAH. RP-HPLC 48 and LC-MS/ MS approach 49,50 were devised to quantify process-related impurities in selexipag API.…”

Section: Selexipagmentioning

confidence: 99%

Analytical Review on Newly Approved Antidiabetic and Antihypertensive Drugs

Pravalika,

2024

IJDDT

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Diabetes and hypertension are the principal causes of death all over the world. Both diabetes and hypertension coexist frequently. Managing both is a multi-faced task requiring extensive care. Therapeutic intervention optimization and ensuring patient safety are the results of assessing medications in biological samples. The development of an analytical technique specific to the measurement of a medicinal chemical in a certain matrix requires careful consideration of the various equipment options and an understanding of their relative capabilities with regard to selectivity, sensitivity, usability, speed of investigation, etc. This article aimed to systematically analyze many popular quantitative analytical techniques for measuring some newly approved antidiabetic and antihypertensive drugs in pharmaceutical planning. Several chromatographic techniques have been employed for quantitative research into these pharmaceuticals. Rapid, accurate, cost-effective, and straightforward drug analysis methods are now essential for developing and using new technologies.

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“…The previously developed methods [5][6][7][8][9][10][11] provide assasys in bulk and pharmaceutical forms, they are not suitable for plasma assays and their sensitivity is not enough for bioanalytical studies. Other MS methods; LC-MS/MS [12,13,[15][16][17] and UPLC-MS/MS [14] were sensitive but they are for rat plasma samples. The proposed method provides sensitive, cost reduced and simple assay of SLP in human plasma.…”

Section: Pharmacokinetic Analysismentioning

confidence: 99%

“…In addition, there are not enough methods that provide pharmacokinetic studies to be easily applicable for the determination of SLP in human plasma. Review of literature revealed that few methods were reported for the estimation of SLP including; spectrophotometric methods [5][6][7], gas chromatograhy [8] and chromatographic methods [9][10][11][12] in dosage form, in addition to, LC-MS/MS methods in plasma [13][14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

A novel HPLC method for selexipag in human plasma and application to a prototype pharmacokinetic study

Ceylan,

Tırıs,

Kepekci Tekkeli

et al. 2023

AChrom

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A novel simple and cost effective HPLC technique was presented for the quantification of selexipag (SLP) in human plasma sample and the technique's applicability to a pharmacokinetic investigation. Chromatographic separation was achieved with C18 (5 µm × 4.6 mm × 150 mm) column, at 30 °C with isocratic elution, mobile phase composed of solution A (acetonitrile), and solution B (0.5% formic acid) (65:35 v/v) at flow rate 1.2 mL min−1. The linearity range is 10–150 ng mL−1. As sample preparation step human plasma was precipitated with acetonitrile and the detection was provided at 300 nm. The retention time is 8.20 ± 0.02 min. LOD is found to be 3.3 ng mL−1 for drug. The method was applied to the analysis of SLP in human plasma with good recovery as 97.83%. Validation of the studied methods was carried out according to EMA guideline. The new method applied on a prototype pharmacokinetic study by administration of 800 μg SLP to a healthy volunteer and parameters like AUC0–24, AUC0–∞, Cmax, tmax, and t1/2 were assessed.

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Development of an efficient stability‐indicating LC–MS/MS method for the analysis of selexipag and characterization of its degradation products

Cited by 5 publications

References 15 publications

A liquid chromatography–tandem mass spectrometry method development for the quantification of favipiravir drug and its related impurities in rat plasma and its application to pharmacokinetic studies

A liquid chromatography–tandem mass spectrometry method development for the quantification of favipiravir drug and its related impurities in rat plasma and its application to pharmacokinetic studies

Analytical Review on Newly Approved Antidiabetic and Antihypertensive Drugs

A novel HPLC method for selexipag in human plasma and application to a prototype pharmacokinetic study

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