A validated reversed phase HPLC method for the determination of process-related impurities in almotriptan malate API

Kumar, Avinash; Ganesh, V.R.L.; Rao, D. V. Subba; Anil, C.; Rao, B. Venugopala; Hariharakrishnan, V.S.; Suneetha, A.; Sundar, B. Syama

doi:10.1016/j.jpba.2007.11.029

Cited by 22 publications

(10 citation statements)

References 3 publications

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“…[1,2]. Different analytical techniques were reported for their determination in different matrices including spectrophotometry [3][4][5][6][7][8], spectrofluorimetry [9][10][11], conductometry [12] and HPLC [13][14][15][16][17][18][19][20]. The complex formation that occurs between a lot of drugs and Eosin Y as an ion pairing agent has been considerably investigated using spectrophotometric and spectrofluorimetric assay of such drugs with or without using of metal [21][22][23][24][25][26][27].…”

Section: Introductionmentioning

confidence: 99%

Validation of Rapid and Sensitive Spectrofluorimetric Assay for Determination of Four Triptans in Pure and Dosage Forms; Application to Human Plasma and Content Uniformity Testing

MA¹,

MA²

2016

Pharm Anal Acta

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A sensitive, simple, rapid and reliable spectrofluorimetric assay was developed for the assay of definite antimigraine drugs namely; Almotriptan malate, Rizatriptan benzoate, Sumatriptan succinate and Zolmitriptan in their pharmaceutical preparations and biological fluid. The suggested procedure was established on determination of the quenching process resulting from the action of the studied drugs on the native fluorescence of Eosin Y via developing of a binary complex reaction between the cited antimigraine preparations and Eosin Y in 0.2 M acetate buffer (pH.3.5). Under the optimized experimental conditions, the relative fluorescence capacity was determined at λ ex =301.3 nm and λ em =542.8 nm. The calibration graphs were linear through extent from 0.07-1.0, 0.20-1.0, 0.2-1.0 and 0.1-1.0 µg/mL, for Almotriptan malate, Rizatriptan benzoate, Sumatriptan succinate and Zolmitriptan, respectively. The detection limits were 0.019, 0.041, 0.055 and 0.032 µg/mL while quantitation limits were 0.059, 0.125, 0.168 and 0.096 µg/mL for Almotriptan malate, Rizatriptan benzoate, Sumatriptan succinate and Zolmitriptan, respectively. The suggested assay has been validated according to ICH and USP guidelines and favorably has been applied to assay of cited drugs in their dosage forms and content uniformity testing. The high sensitivity of the developed assay allowed quantification of the studied antimigraine drugs in human plasma.

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Section: Introductionmentioning

confidence: 99%

Validation of Rapid and Sensitive Spectrofluorimetric Assay for Determination of Four Triptans in Pure and Dosage Forms; Application to Human Plasma and Content Uniformity Testing

MA¹,

MA²

2016

Pharm Anal Acta

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“…A validated reverse phase HPLC method for the determination of process related impurities in almotriptan malate API was reported earlier. 7 Literature survey reveals that no analytical method for determination of almotriptan malate in pharmaceutical dosage forms is reported. So it is felt worth while to develop a simple, rapid, accurate, precise and more economical high performance liquid chromatographic method for determination of almotriptan in bulk and its pharmaceutical dosage form.…”

Section: Introductionmentioning

confidence: 99%

A Validated RP HPLC Method for Estimation of Almotriptan Malate in Pharmaceutical Dosage Form

Suneetha

Syama

2010

J Chinese Chemical Soc

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An accurate, sensitive, precise and robust reverse phase high performance liquid chromatographic method for the estimation of almotriptan malate in pharmaceutical dosage form has been developed and validated. Chromatographic separation was conducted on Phenomenex Gemini C18 (250 mm´4.6 mm, 5m) column at room temperature using potassium dihydrogen phosphate buffer: acetonitrile (80:20) as a mobile phase, pH adjusted to 3.2 ± 0.1 with 10% sodium hydroxide and at a flow rate of 1.5 mL min -1 , while UV detection was performed at 227 nm. The retention time for almotriptan malatewas found to be 9.47 ± 0.05 min. The method was found to be linear in the range of 1.0-10.0 mg mL -1 . The limit of detection and quantitation for almotriptan malate were found to be 0.03 and 0.1 mg mL -1 , respectively. Analytical recovery was > 99.87%. The method was validated stastically and applied for the quantitative analysis of almotriptan malate in bulk and formulations.

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“…Most organic impurities in drugs are profiled by chromatographic methods of which reversed-phase HPLC [1][2][3][4][5] and thin layer chromatography (TLC) [6] coupled with UV or fluorescent detection have been the most popular for well over a decade. Other approaches reported for impurity profiling involve HPLC-mass spectrometry (MS), gas chromatography (GC) combined with flame ionization [7] or MS [8] detection, as well as some non-chromatographic strategies such as atomic absorption spectrometry [9], fluorimetry [10], UV [11], polarography [12] and nuclear magnetic resonance spectroscopy [13].…”

Section: Introductionmentioning

confidence: 99%

Capillary electrophoresis–electrochemiluminescent detection of N,N-dimethyl ethanolamine and its application in impurity profiling and stability investigation of meclophenoxate

Fu¹,

Wang²,

Wang³

2009

Analytica Chimica Acta

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A validated reversed phase HPLC method for the determination of process-related impurities in almotriptan malate API

Cited by 22 publications

References 3 publications

Validation of Rapid and Sensitive Spectrofluorimetric Assay for Determination of Four Triptans in Pure and Dosage Forms; Application to Human Plasma and Content Uniformity Testing

Validation of Rapid and Sensitive Spectrofluorimetric Assay for Determination of Four Triptans in Pure and Dosage Forms; Application to Human Plasma and Content Uniformity Testing

A Validated RP HPLC Method for Estimation of Almotriptan Malate in Pharmaceutical Dosage Form

Capillary electrophoresis–electrochemiluminescent detection of N,N-dimethyl ethanolamine and its application in impurity profiling and stability investigation of meclophenoxate

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