Stability-Indicating HPLC method for estimation of omarigliptin in tablets – Oxidative and photolytic kinetics and degradation products formed under oxidative conditions

Emanuelli, Juliana; Schapoval, Elfrides Eva Scherman

doi:10.1016/j.microc.2020.105084

Cited by 9 publications

(5 citation statements)

References 23 publications

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“…The literature review showed that few reported methods were available for determination of OMG either alone or in combination with other drugs. These methods comprise HPLC [ 8 – 10 ], spectrofluorimetry [ 11 ], spectrophotometry [ 12 ], and LC-MS/MS [ 13 ]. Concerning MET, a number of reported methods was available including HPLC [ 14 – 20 ], spectrophotometry [ 21 – 24 ], spectrofluorimetry [ 25 , 26 ], LC-MS/MS [ 27 – 30 ], and TLC [ 31 , 32 ].…”

Section: Introductionmentioning

confidence: 99%

Analytical quality-by-design approach for development and validation of HPLC method for the simultaneous estimation of omarigliptin, metformin, and ezetimibe: application to human plasma and dosage forms

et al. 2023

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A simple, selective, and sensitive RP-HPLC method was proposed for the simultaneous determination of two co-administered antidiabetic drugs (omarigliptin and metformin) with an anti-hyperlipidemic drug (ezetimibe) in a medicinally-recommended ratio of 2.5:50:1, respectively. The proposed procedure was optimized by adopting a quality-by-design approach. The influence of different factors on chromatographic responses was optimized by applying the two-level full factorial design (25). The optimum chromatographic separation was achieved using Hypersil BDS C18 column at 45 °C, and the mobile phase pumped isocratically composed of methanol: potassium dihydrogen phosphate buffer (6.6 mM; pH 7, 67:33% v/v) at a flow rate of 0.814 mL/min using 235 nm as a detection wavelength. The developed method was capable of separating this novel mixture in less than 8 min. The calibration plots of omarigliptin, metformin, and ezetimibe showed acceptable linearity over the ranges of 0.2-2.0, 0.5–25.0, and 0.1-2.0 µg/mL with quantitation limits of 0.06, 0.50, and 0.06 µg/mL, respectively. The proposed method was successfully applied to determine the studied drugs in their commercial tablets with high % recoveries (96.8-102.92%) and low % RSD values (less than 2%). The applicability of the method was extended to the in-vitro assay of the drugs in spiked human plasma samples with high % recoveries (94.3-105.7%). The suggested method was validated in accordance with ICH guidelines.

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Section: Introductionmentioning

confidence: 99%

Analytical quality-by-design approach for development and validation of HPLC method for the simultaneous estimation of omarigliptin, metformin, and ezetimibe: application to human plasma and dosage forms

et al. 2023

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“…ICH guidelines [18] require developing stability indicating assay methods (SIAM) for active ingredients to elucidate drug inherent stability with time [19]; also, the linear regression analysis of degradation with time is required [20,21]. Degradation kinetics and pH profiling is required [22] for determining optimum storage conditions and predicting shelf life of drug [23,24].…”

Section: Introductionmentioning

confidence: 99%

Stability indicating RP‐HPLC method for methylcobalamin determination in different dosage forms: Application to photodegradation kinetics and pH rate profiling

Amer

Kamal

Hammad

et al. 2022

J of Separation Science

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A stability‐indicating RP‐HPLC method for methylcobalamin determination was developed. Stress degradation under variable conditions was carried out. Methylcobalamin had pronounced susceptibility to hydrolysis under acidic, alkaline, and photolytic conditions; further study of photolytic degradation kinetics and pH rate profiling over pH range 2–11 was carried out. Photodegradation of methylcobalamin followed zero‐order kinetics with half‐life 0.99 h equivalent to 1971.53 lux. Methylcobalamin followed pseudo‐first‐order kinetics upon exposure to acidic and alkaline hydrolysis with highest stability at pH 5 and least stability at pH 2. Optimization of chromatographic conditions was performed using two level full factorial design, and chromatographic analysis was executed using Inertsil column (250 × 4.6 mm, 5 μm) maintained at 25◦C. Elution was carried out using 25 mM potassium dihydrogen phosphate (pH adjusted with phosphoric acid to 3.8): methanol:acetonitrile (55:35:10, v/v) as mobile phase. The flow rate was 1.0 ml/min. Detection was carried out at 220 nm using diode array detector. The method was validated as per ICH guidelines; the linearity was over concentration range 2–160 μg/ml with coefficient of determination 0.9995. The method was effectively applied for determination of methylcobalamin in Cobalvex ampoule, Cobal tablet, Cobal‐F tablet, and Methyltechon oral dissolvable film without interfering from excipients within run time 6 min.

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“…It is a recent antidiabetic drug used for treatment of type II diabetes mellitus [18]. OMR is one of the dipeptidyl peptidase-4 inhibitors, and it has an advantage over other drugs belonging to the same class in being administrated once weekly [19]. By such mechanism, enhancement in insulin secretion along with a diminished glucagon release are achieved [20,21].…”

Section: Introductionmentioning

confidence: 99%

“…Being recently developed drug, OMR has not yet been listed in any pharmacopeia [22][23][24]. Literature survey revealed that different analytical techniques have been developed for OMR determination such as spectrofluorometry [17] and chromatography [19,[25][26][27]. Moreover, our previously reported stability study revealed that the drug was susceptible to hydrolytic and oxidative degradations [27].…”

Section: Introductionmentioning

confidence: 99%

A New Comparative Potentiometric Method for Analysis of Omarigliptin Using Three Different Sensors

et al. 2022

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This work represents first attempt for potentiometric determination of the most recent antidiabetic; omarigliptin. Three sensors, employing potassium tetrakis (p-chlorophenyl) borate as a lipophilic cation exchanger, were developed and compared. One liquid contact ionselective electrode and two carbon paste-based solid contact ones, plain one and another one modified with polyaniline nanoparticles, were employed. Performances of fabricated sensors were assessed as per IUPAC recommendations. Incorporation of hydrophobic polyaniline nanoparticles as ion-to-electron transducer layer at solid contact/ion-sensitive membrane interface enhanced sensitivity and stability of the third sensor showing LOD of 2.5 × 10 À 7 mol L À 1 and slope of 58.57 mV decade À 1 . The three sensors were applied for omarigliptin determination in presence of its degradation products, in dosage form and spiked human plasma.

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Stability-Indicating HPLC method for estimation of omarigliptin in tablets – Oxidative and photolytic kinetics and degradation products formed under oxidative conditions

Cited by 9 publications

References 23 publications

Analytical quality-by-design approach for development and validation of HPLC method for the simultaneous estimation of omarigliptin, metformin, and ezetimibe: application to human plasma and dosage forms

Analytical quality-by-design approach for development and validation of HPLC method for the simultaneous estimation of omarigliptin, metformin, and ezetimibe: application to human plasma and dosage forms

Stability indicating RP‐HPLC method for methylcobalamin determination in different dosage forms: Application to photodegradation kinetics and pH rate profiling

A New Comparative Potentiometric Method for Analysis of Omarigliptin Using Three Different Sensors

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