Study of impurity carryover and impurity profile in Febuxostat drug substance by LC–MS/MS technique

Kadivar, Mustakhusen H.; Sinha, Parikhit; Kushwah, Dharmendra Kumar; Jana, Pijush; Sharma, Hitesh; Bapodra, Atul H.

doi:10.1016/j.jpba.2011.07.039

Cited by 16 publications

(12 citation statements)

References 4 publications

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“…Liquid chromatography -Mass spectrometry (LC) (Kadivar et al 2011;Ding et al 2012;Wang et al 2012). These methods have been reported for the quantitative estimation of Febuxostat in pharmaceutical (Bagga et al 2011;Sheth et al 2012;Gunda et al 2012a;Kumaraswamy Gandla et al 2012;Cong et al 2010;Naresh Chandra Reddy & Chandra Sekhar 2012;Nageswara Rao et al 2012;Gunda et al 2012b;Muvvala1 et al 2012;Sahu et al 2012;Kadivar et al 2011) and biological fluids (Yamamoto et al 1995;2011;Menon et al Lukram et al 2012;Zhang et al 2012;Ding et al 2012;Wang et al 2012). Among all Quantification of Febuxostat in biological matrices by using LC-MS/MS (Ding et al 2012;Wang et al 2012) were reported.…”

Section: Introductionmentioning

confidence: 99%

Bioequivalance and pharmacokinetic study of febuxostat in human plasma by using LC-MS/MS with liquid liquid extraction method

et al. 2013

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A bioequivalence study was proved of generic Febuxostat 80 mg tablets (T) in healthy volunteers.For this purpose, Authors developed a simple, sensitive, selective, rapid, rugged and reproducible liquid chromatography–tandem mass spectrometry method for the quantification of Febuxostat (FB) in human plasma using Febuxostat D7 (FBD7) as an internal standard (IS) was used. Chromatographic separation was performed on Ascentis Express C18 (50x4.6 mm, 3.5 μ) column. Mobile phase composed of 10 mM Ammonium formate: Acetonitrile (20:80 v/v), with 0.8 mL/min flow-rate. Drug and IS were extracted by Liquid- liquid extraction. FB and FBD7 were detected with proton adducts at m/z 317.1→261.1 and 324.2→262.1 in multiple reaction monitoring (MRM) positive mode respectively. The method was validated with the correlation coefficients of (r2) ≥ 0.9850 over a linear concentration range of 1.00-8000.00 ng/mL. This method demonstrated intra and inter-day precision within 2.64 to 3.88 and 2.76 to 8.44% and accuracy within 97.33 to 99.05 and 100.30 to 103.19% for FB. This method is successfully applied in the Bioequivalence study of 9 human volunteers.

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Section: Introductionmentioning

confidence: 99%

Bioequivalance and pharmacokinetic study of febuxostat in human plasma by using LC-MS/MS with liquid liquid extraction method

et al. 2013

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“…[1,2] It is a potential alternative to allopurinol for patients with hyperuricemia and gout. [12,13] To the best of our knowledge, there is no published literature for the determination of febuxostat using ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) for pharmacokinetic and bioequivalence studies. [3] Febuxostat has minimal effect on other enzymes involved in purine and pyrimidine metabolism, and it is metabolized mainly by glucuronide formation and oxidation in the liver.…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, although HPLC-Ultraviolet/Visible and liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods have been developed for the determination of febuxostat, they are limited to analyze the pharmaceutical preparation in vitro and are not suitable for pharmacokinetic analysis in human plasma. [12,13] To the best of our knowledge, there is no published literature for the determination of febuxostat using ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) for pharmacokinetic and bioequivalence studies. Although Khosravan et al [14,15] developed a method for the determination of febuxostat and its metabolite by LC-MS/MS, this method is limited to the drug metabolism and pharmacokinetic study, but is not suitable for routine analysis of samples obtained from bioequivalence and bioavailability studies.…”

Section: Introductionmentioning

confidence: 99%

Determination of febuxostat in human plasma using ultra‐performance liquid chromatography tandem mass spectrometry

Lukram¹,

Parmar²,

Hande³

2012

Drug Testing and Analysis

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A rapid and sensitive liquid chromatography-tandem mass spectrometry method has been developed and validated for the determination of febuxostat in human plasma. The liquid-liquid extraction technique was used for the extraction of febuxostat from human plasma using trandolapril as the internal standard (IS). Chromatography was performed on a ultra-performance liquid chromatography (UPLC) BEH C18, 50 mm X 2.1 mm, 1.7 µm particle size column, with the mobile phase consisting of 0.1% formic acid and acetonitrile (in a 25:75 ratio), followed by detection using mass spectrometry. The method involves a simple reversed isocratic chromatography condition and mass spectrometry detection, which enables detection at sub-microgram levels. The method was validated and the lower limit of quantification for febuxostat was found to be 0.075 µg/ml. The mean recovery for febuxostat ranged from 100.9 to 106.5%. This method increased the sensitivity and selectivity; resulting in high-throughput analysis of febuxostat using commercially available IS for pharmacokinetic, bioavailability, and bioequivalence studies, with a chromatographic run time of 1.5 min only.

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“…3,4 A gradient RP-LC-MS/MS method using a C 18 column and detection at 315 nm has been applied to identify the prole of impurities present in the active pharmaceutical ingredient (API) of synthetic febuxostat. 5 An isocratic UPLC method has also been validated for use in forced degradation studies for febuxostat API only, using a C 18 column and detection at 315 nm. 6 An isocratic RP-LC method has been validated for the analysis of febuxostat in pharmaceutical formulations using a C 18 column with detection at 316 nm.…”

Section: Febuxostatmentioning

confidence: 99%

Validation of a stability-indicating micellar electrokinetic capillary method for the assessment of febuxostat and its correlation with the reversed-phase LC method

et al. 2014

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Study of impurity carryover and impurity profile in Febuxostat drug substance by LC–MS/MS technique

Cited by 16 publications

References 4 publications

Bioequivalance and pharmacokinetic study of febuxostat in human plasma by using LC-MS/MS with liquid liquid extraction method

Bioequivalance and pharmacokinetic study of febuxostat in human plasma by using LC-MS/MS with liquid liquid extraction method

Determination of febuxostat in human plasma using ultra‐performance liquid chromatography tandem mass spectrometry

Validation of a stability-indicating micellar electrokinetic capillary method for the assessment of febuxostat and its correlation with the reversed-phase LC method

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