The practical application of implementing the equimolar response principle of chemiluminescent nitrogen detection in pharmaceutical analysis

Liang, Xiongshun; Patel, H.; Young, Joel; Shah, Pankaj A.; Raglione, Thomas

doi:10.1016/j.jpba.2008.02.026

Cited by 15 publications

(4 citation statements)

References 29 publications

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“…RID exhibits a 272 rather low sensitivity and is not only sensitive to temperature and flow change, but is also 273 incompatible with gradient elution. The absence of nitrogen atoms in the structure of β-274 artemether renders the CLND technique useless, as the response is directly proportional to the 275 nitrogen content [25][26][27]. The ELSD and CAD techniques record only non-or semi-volatile 276 compounds after evaporation of column eluent, often with inherent sensor noise and drift, 277 being sensitive to the mobile phase composition [28][29][30].…”

Section: Page 8 Of 23mentioning

confidence: 99%

“…However, this is clearly not the case for the β-artemether degradants. Instead of 302 the elaborate isolation of each degradant, or the simultaneous use of universal detectors with 303 their uncertainty of variable response [11,25] we have solved this question of negative mass 304 balance deficit using a new stress approach, performed in different time (minutes) and 305 temperature (125 °C -150 °C) space compared to current pharmaceutical stress conditions 306 [32][33][34]. Stringham et al, reported an RRF range for the synthesis impurity artemisitene, i.e.…”

Section: Page 8 Of 23mentioning

confidence: 99%

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Relative response factor determination of β-artemether degradants by a dry heat stress approach

Spiegeleer

D׳Hondt

Vangheluwe

et al. 2012

Journal of Pharmaceutical and Biomedical Analysis

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Relative response factor determination of rmbeta-artemether degradants by a dry heat stress approach, Journal of Pharmaceutical and Biomedical Analysis (2010), doi:10.1016/j.jpba.2012 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. During the stability evaluation of -artemether containing finished drug products, a consistent 20 and disproportional increase in the UV-peak areas of -artemether degradation products, 21 when compared to the peak area decline of -artemether itself, was observed. This suggested 22 that the response factors of the formed -artemether degradants were significantly higher than 23 β-artemether. Dry heat stressing of -artemether powder, as a single compound, using 24 different temperatures (125 °C -150 °C), times (10 min -90 min) and environmental 25 conditions (neutral, KMnO 4 and zinc), resulted in the formation of 17 degradants. The vast 26 majority of degradants seen during the long-term and accelerated ICH stability study of the 27 drug product, were also observed here. The obtained stress results allowed the calculation of 28 the overall average relative response factor (RRF) of -artemether degradants, i.e. 21.2, 29 whereas the individual RRF values of the 9 most prominent selected degradants ranged from 30 4.9 to 42.4. Finally, Ames tests were performed on -artemether as well as a representative 31 stressed sample mixture, experimentally assessing their mutagenic properties. Both were 32 found to be negative, suggesting no mutagenicity problems of the degradants at high 33 concentrations. Our general approach and specific results solve the developmental quality 34 issue of mass balance during stability studies and the related genotoxicity concerns of the key 35 antimalarial drug -artemether and its degradants. 36

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Section: Page 8 Of 23mentioning

confidence: 99%

Section: Page 8 Of 23mentioning

confidence: 99%

Relative response factor determination of β-artemether degradants by a dry heat stress approach

Spiegeleer

D׳Hondt

Vangheluwe

et al. 2012

Journal of Pharmaceutical and Biomedical Analysis

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“…129,130 The HPLC/CLND system has some applications in pharmaceutical industries. [131][132][133] For the identification purpose, the LC/CLND can provide additional information on the identity of the compound. In the study of granulate materials containing two components: one excipient (HPC) and one drug substance containing amine groups, the stressed processing material was found to have an extra peak at around 12 min in the chromatogram using sizeexclusion chromatography interfaced with a nitrogen detector (SEC/CLND).…”

Section: Size-exclusion Chromatography/chemiluminescent Nitrogen Detementioning

confidence: 99%

Identification of Pharmaceutical Impurities in Formulated Dosage Forms

Pan

Liu

Motto

2011

Journal of Pharmaceutical Sciences

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“…Gregory et al 4 has reported the determination of relative Responses factor (RRF) using NMR spectrophotometer in absence of any authentic standards 4 . Liang et al 5 used chemiluminescent nitrogen detection in pharmaceutical analysis for the determination of equimolar response for nitrogen present in impurities 5 . A formula for the determination of relative response factors was derived for butter oil fatty acids and a regression line representing the best fit of the equation was calculated by Steen et al 6 using gas chromatography 6 .…”

Section: Introductionmentioning

confidence: 99%

Practical Approach for the Determination of Response Factors of Impurities in Drugs by HPLC

Kushwah¹,

Patel²,

Sinha³

et al. 2011

Journal of Chemistry

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For the determination of accurate quantity of impurities in the samples authentic impurity standards or response factors at a given wavelength must be known. In the presented work a convenient method for determination of relative response factors of impurities has been described without using an authentic impurities standard. An approach for the determination of response factors of the impurities where impurity standard is physically not available was developed and verified using different approaches. One such method was developed and verified by RP-HPLC using Cosmosil C18 MS-II column at UV 238 nm. Two different approaches were employed and the verification of correctness of approach was done using a known related substance of known response factor.

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The practical application of implementing the equimolar response principle of chemiluminescent nitrogen detection in pharmaceutical analysis

Cited by 15 publications

References 29 publications

Relative response factor determination of β-artemether degradants by a dry heat stress approach

Relative response factor determination of β-artemether degradants by a dry heat stress approach

Identification of Pharmaceutical Impurities in Formulated Dosage Forms

Practical Approach for the Determination of Response Factors of Impurities in Drugs by HPLC

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