Application of Liquid Chromatography Coupled With Mass Spectrometry in the Impurity Profiling of Drug Substances and Products

Akshatha, H S; Gurupadayya, Bannimath

doi:10.22159/ajpcr.2018.v11i5.24212

Cited by 5 publications

(3 citation statements)

References 10 publications

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“…It is preferred for the separation of complex mixtures of proteins, peptides and drug metabolites (Snyder et al 2011 ). In the usual analysis of macromolecules such as proteins or peptides, there may be some challenges such as complexity, wide range of concentration, differently expressed proteins during cell development, low-level expression for certain components, sample preparation at microlevel and availability (Akshatha and Gurupadayya 2018 ; Snyder et al 2011 ). To overcome these difficulties, multiplexed diagnostic stages are being built up which allow high throughput and precise outcomes.…”

Section: Types Of Microfluidic Chips Based On Device Configurationmentioning

confidence: 99%

“…It can also perform exact and precise sample dealing operations. Due to these advantages, microfluidic technology is combined with LC for the biomolecule analysis (Akshatha and Gurupadayya 2018 ; Huft et al 2013 ). Microfluidic LC devices are fabricated by photolithography and wet-chemical etching.…”

Section: Types Of Microfluidic Chips Based On Device Configurationmentioning

confidence: 99%

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Microfluidic chips: recent advances, critical strategies in design, applications and future perspectives

Pattanayak

Singh

Gulati

et al. 2021

Microfluid Nanofluid

149

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Microfluidic chip technology is an emerging tool in the field of biomedical application. Microfluidic chip includes a set of groves or microchannels that are engraved on different materials (glass, silicon, or polymers such as polydimethylsiloxane or PDMS, polymethylmethacrylate or PMMA). The microchannels forming the microfluidic chip are interconnected with each other for desired results. This organization of microchannels trapped into the microfluidic chip is associated with the outside by inputs and outputs penetrating through the chip, as an interface between the macro- and miniature world. With the help of a pump and a chip, microfluidic chip helps to determine the behavioral change of the microfluids. Inside the chip, there are microfluidic channels that permit the processing of the fluid, for example, blending and physicochemical responses. Microfluidic chip has numerous points of interest including lesser time and reagent utilization and alongside this, it can execute numerous activities simultaneously. The miniatured size of the chip fastens the reaction as the surface area increases. It is utilized in different biomedical applications such as food safety sensing, peptide analysis, tissue engineering, medical diagnosis, DNA purification, PCR activity, pregnancy, and glucose estimation. In the present study, the design of various microfluidic chips has been discussed along with their biomedical applications.

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Section: Types Of Microfluidic Chips Based On Device Configurationmentioning

confidence: 99%

Section: Types Of Microfluidic Chips Based On Device Configurationmentioning

confidence: 99%

Microfluidic chips: recent advances, critical strategies in design, applications and future perspectives

Pattanayak

Singh

Gulati

et al. 2021

Microfluid Nanofluid

149

View full text Add to dashboard Cite

show abstract

“…LC-MS is a popular and versatile hyphenated technique used for the determination of related substances and impurities at parts per million levels 14 . The literature search disclosed that few methods were developed for estimation of Oseltamivir API alone by HPLC [15][16] , LC/MS/MS 17 , Spectrophotometry 18 , Desorption electro spray ionization mass spectrometry (DESI-MS) 19 .…”

Section: Lc-ms As Detection Techniquementioning

confidence: 99%

Method Development and Validation for the Trace Level Quantification of Genotoxic Impurity Oseltamivir Phosphate Related Compound-a in Oseltamivir Phosphate Using LC-MS

Viswanath¹,

Reddy²,

Nagaraju

2021

Orient. J. Chem

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A selective and sensitive method has been developed for the determination of ethyl-(3S,4R,5S)-4-acetamido-5-amino-2-azido-3-(pentan-3-yloxy)cyclohexanecarboxylate (OSPRC-A) by using liquid chromatography coupled with mass spectrometer with single mass analyzer (LC-MS).The method was developed by using column DEVELOSIL ODS-UG-5, (50×3.0 mm, 5.0 µm) with linearity range of 0.005% to 0.0151% which meets to quantification level of 150% range. The column oven temperature was maintained at 40ºC. The flow rate was set as 1.5 mL/min. Injection volume was 10 µL and the detection wavelength was 215 nm. The signal to noise ratio values obtained were found to be 4.79 at concentration level of 0.00015% for the limit of detection (LOD) and 13.46 at concentration level of 0.0005% for the limit of quantification (LOQ). The % recovery was found to be in between the range 80.0% to 101.32% at LOQ to 150% level. The result obtained in method precision and intermediate precision are found to be within the specification limit. The percentage RSD for the content of OSPRC-A of method precision was 4.26. The percentage RSD for the content of OSPRC-A for intermediate precision was 4.00. The sample prepared in analytical solution was found to be stable for 24 h. This method can be used for the identification of impurity, OSPRC-A in Oseltamivir phosphate drug substances in its manufacturing.

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LC-MS/MS STUDY OF THE TRACE LEVEL IMPURITIES OF IRBESARTAN AN ANGIOTENSIN II RECEPTOR ANTAGONIST MOLECULE TO ITS ORIGIN THROUGH nMS2 TECHNIQUE

Saravanan

Ansari²

2019

Int J Pharm Pharm Sci

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Objective: The mass characterization of five trace level related impurities of Irbesartan was performed through the “nMS2” technique of triple quadrupole mass spectrometer and also to Correlated to the impurity origin.Methods: A simple & effective patented process was applied to get the impurity profile, and mass characterization was performed through the “nMS2” technique of triple quadrupole mass spectrometer analyser.Results: The simple production scan in differential collision energies is coined as “nMS2” technique of the triple quadrupole analyzer. The molecular ion fragmentation occurs with multiple collision energies and provides meaningful MSMS fragments for characterizing five trace level impurities less than 0.5% of angiotensin II receptor antagonist-Irbesartan. The origin of the impurity formation in the synthetic process was successfully related to the Spiro ketones.Conclusion: The results obtained in this research clearly indicates the approach of “nMS2” technique was very useful in the identification and structural prediction of trace level related impurities of Irbesrtan.

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Application of Liquid Chromatography Coupled With Mass Spectrometry in the Impurity Profiling of Drug Substances and Products

Cited by 5 publications

References 10 publications

Microfluidic chips: recent advances, critical strategies in design, applications and future perspectives

Microfluidic chips: recent advances, critical strategies in design, applications and future perspectives

Method Development and Validation for the Trace Level Quantification of Genotoxic Impurity Oseltamivir Phosphate Related Compound-a in Oseltamivir Phosphate Using LC-MS

LC-MS/MS STUDY OF THE TRACE LEVEL IMPURITIES OF IRBESARTAN AN ANGIOTENSIN II RECEPTOR ANTAGONIST MOLECULE TO ITS ORIGIN THROUGH nMS2 TECHNIQUE

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