A Lc-MS/MS Method for the Quantification of Deflazacort Metabolite in Human Plasma: Development, Validation and Application to a Pharmacokinetic Study

Karthikeyan, Sarita

doi:10.22270/jddt.v3i2.397

Cited by 6 publications

(3 citation statements)

References 4 publications

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“…Sharma et al and More et al also investigated the stability of deflazacort in dosage form by HPLC method; however, the analysis was restricted to hydrolysis, photolysis and chemical oxidation [ 26 - 27 ] . Recently, Karthikeyan et al have reported a LC-MS method for estimation of deflazacort products in human plasma [ 28 ] . Patel et al reported an ultra-performance liquid chromatography–tandem mass spectrometric method for the determination of 21-hydroxy deflazacort in human plasma using betamethasone as the internal standard [ 29 ] .…”

Section: Introductionmentioning

confidence: 99%

Force degradation behavior of glucocorticoid deflazacort by UPLC: isolation, identification and characterization of degradant by FTIR, NMR and mass analysis

Deshmukh¹,

Sharma

Tekade³

et al. 2016

J Biomed Res

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In this investigation, sensitive and reproducible methods are described for quantitative determination of deflazacort in the presence of its degradation product. The method was based on high performance liquid chromatography of the drug from its degradation product on reverse phase using Acquity UPLC BEH C18 columns (1.7 µm, 2.1 mm × 150 mm) using acetonitrile and water (40:60 V/V) at a flow rate of 0.2 mL/minute in UPLC. UV detection was performed at 240.1 nm. Deflazacort was subjected to oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The drug was found to be stable in water and thermal stress, as well as under neutral stress conditions. However, forced-degradation study performed on deflazacort showed that the drug degraded under alkaline, acid and photolytic stress. The degradation products were well resolved from the main peak, which proved the stability-indicating power of the method. The developed method was validated as per ICH guidelines with respect to accuracy, linearity, limit of detection, limit of quantification, accuracy, precision and robustness, selectivity and specificity. Apart from the aforementioned, the results of the present study also emphasize the importance of isolation characterization and identification of degradant. Hence, an attempt was made to identify the degradants in deflazacort. One of the degradation products of deflazacort was isolated and identified by the FTIR, NMR and LC-MS study.

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Section: Introductionmentioning

confidence: 99%

Force degradation behavior of glucocorticoid deflazacort by UPLC: isolation, identification and characterization of degradant by FTIR, NMR and mass analysis

Deshmukh¹,

Sharma

Tekade³

et al. 2016

J Biomed Res

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“…The mean terminal half-life (t ½ ) is around 60-80 h. MEM and its metabolites are primarily eliminated through urine (75-90%) and the remaining recovered through bile and feces. 4,5 Majority of the LC-MS/MS methods have been reported for estimation of MEM in clinical studies [6][7][8][9][10][11][12] and one method to support preclinical study. Among these methods the lowest reported lower limit of quantification (LLOQ) was 0.05 ng/ml using 100 µl plasma.…”

Section: Introductionmentioning

confidence: 99%

Highly Sensitive LC-MS/MS Method for Determinationof Memantine in Rat Plasma: Application to Pharmacokinetic Studies in Rats

Suresh¹,

Mullangi²,

Kumar³

2014

IJPER

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Background: A rapid and highly sensitive assay method has been developed and validated for the estimation of memantine (MEM) in rat plasma using liquid chromatography coupled to tandem mass spectrometry with electro spray ionization in the positive-ion mode. Method validation was performed as per United States Food and Drug Administration (US FDA) guidelines. Methods: The assay procedure involves a simple liquid-liquid extraction of MEM and phenacetin (internal standard, IS) from rat plasma using methyl tert-butyl methyl ether. Chromatographic separation was achieved with 0.2% formic acid: acetonitrile (40:60, v/v) at a flow rate of 0.50 ml/min on an Atlantis dC18 column with a total run time 3.0 min. The MS/MS ion transitions monitored were 180.10 ® 163.30 for MEM and 180.10 ® 110.10 for IS. Results: The results met the acceptance criteria mentioned in the guidelines. The lower limit of quantitation achieved was 0.025 ng/ml and the linearity was observed from 0.025 to 220 ng/ml. The intra-and inter-day precision was in the range of 0.88-6.84 and 2.57-6.79%, respectively. Conclusions: An LC-ESI-MS/MS for the determination of MEM in rat plasma employing simple liquidliquid extraction was developed and validated with high sensitivity and selectivity. This novel method has been applied to a pharmacokinetic study in rats.

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“…16 13. A reverse phase HPLC method for pharmaceutical dosage form deflazacort assessment is simple, specific, fast, and efficient.…”

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confidence: 99%

A Comprehensive Review of Deflazacort with Special Reference to Pharmacological Profile and Pharmaceutical Validation Processes

Pund¹,

Changediya²,

Rajurkar³

2022

IJDDT

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Deflazacort is a prednisolone-derived immunosuppressant and anti-inflammatory. It controls cytokines and immune cell development. It may increase muscle cell proliferation and reduce muscle breakdown to enhance Duchenne muscular dystrophy muscle strength and function. Pharmaceutical companies aim to produce high-quality drugs at low prices. Pharmaceutical formulation discovery, development, and evaluation require validated methods. Validation ensures quality and reliability throughout the manufacturing process. The validation procedure evaluates accuracy, specificity, precision, and system applicability to guarantee the analytical technique used to analyze medicine-related samples is reliable. This paper describes the deflazacort technique development and validation. Google Scholar, Pub-Med, and Shodganga are utilized to gather information.

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A Lc-MS/MS Method for the Quantification of Deflazacort Metabolite in Human Plasma: Development, Validation and Application to a Pharmacokinetic Study

Cited by 6 publications

References 4 publications

Force degradation behavior of glucocorticoid deflazacort by UPLC: isolation, identification and characterization of degradant by FTIR, NMR and mass analysis

Force degradation behavior of glucocorticoid deflazacort by UPLC: isolation, identification and characterization of degradant by FTIR, NMR and mass analysis

Highly Sensitive LC-MS/MS Method for Determinationof Memantine in Rat Plasma: Application to Pharmacokinetic Studies in Rats

A Comprehensive Review of Deflazacort with Special Reference to Pharmacological Profile and Pharmaceutical Validation Processes

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