Interlaboratory studies on two high-performance liquid chromatographic assays for tylosin (tartrate)

Heyden, Yvan Vander; Saevels, Jan; Roets, Eugène; Hoogmartens, Jos; Decolin, D.; Quaglia, M.G.; Bossche, W. Van den; Leemans, R.; Smeets, Oscar; Vaart, F. Van de; Mason, Bruce D.; Taylor, G. C.; Underberg, W.J.M.; Bult, A.; Chiap, Patrice; Crommen, Jacques; Beer, Jacques O. De; Hansen, S. H.; Massart, D.L.

doi:10.1016/s0021-9673(98)00840-1

Cited by 21 publications

(13 citation statements)

References 3 publications

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“…A G test for a polar pair (one low and one high result) was also used [38]. The different formulas applied in Mandel's, Cochran and Grubbs' tests are detailed elsewhere [36,37,39].…”

Section: Statistical Analysis Of the Resultsmentioning

confidence: 99%

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Interlaboratory study of a NACE method for the determination of R‐timolol content in S‐timolol maleate: Assessment of uncertainty

et al. 2006

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Analyses of statistical variance were applied to evaluate the precision and practicality of a CD-based NACE assay for R-timolol after enantiomeric separation of R- and S-timolol. Data were collected in an interlaboratory study by 11 participating laboratories located in Europe and North America. General qualitative method performance was examined using suitability descriptors (i.e. resolution, selectivity, migration times and S/N), while precision was determined by quantification of variances in the determination of R-timolol at four different impurity levels in S-timolol maleate samples. The interlaboratory trials were designed in accordance with the ISO guideline 5725-2. This allowed estimating for each sample, the different variances, i.e. between-laboratory (s2(Laboratories)), between-day (s2(Days)) and between-replicate (s2(Replicates)). The variances of repeatability (s2r) and reproducibility (s2R) were then calculated. The estimated uncertainty, derived from the precision estimates, seems to be concentration-dependent above a given threshold. This example of R-timolol illustrates how a laboratory can evaluate uncertainty in general.

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“…A G test for a polar pair (one low and one high result) was also used [38]. The different formulas applied in Mandel's, Cochran and Grubbs' tests are detailed elsewhere [36,37,39].…”

Section: Statistical Analysis Of the Resultsmentioning

confidence: 99%

“…Commonly, in interlaboratory studies, e.g. in [36,37], only the top and bottom levels of the experimental design are performed, i.e. different laboratories and within each laboratory two replicates.…”

Section: Setup Of the Studymentioning

confidence: 99%

Interlaboratory study of a NACE method for the determination of R‐timolol content in S‐timolol maleate: Assessment of uncertainty

et al. 2006

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“…The calculations involved in these types of trials are fairly extensive. Several examples are provided within ISO 5725, and Vander Heyden et al provides a detailed example for an interlaboratory trial for an HPLC procedure [19].…”

Section: Precisionmentioning

confidence: 99%

Method Validation Approaches for Pharmaceutical Assessments – Highlights with High Performance Thin Layer Chromatographic (HPTLC) Techniques

Jenkins¹,

Diallo²,

Bethea³

et al. 2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

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Method validation is an important activity for pharmaceutical evaluations to ensure that analytical methods are suitable for their intended use. With particular focus on active ingredient and impurities, the implementation of different categories of method validation are explained for qualitative and quantitative methods. Detailed explanations with example approaches are provided for the key aspects of method validation, namely specificity, accuracy, linearity, limits of detection/quantitation, precision, robustness, and method range. While all of the sections outlined for method validation are generally applicable for a variety of techniques commonly used in pharmaceutical analysis (i.e., UV and HPLC instrumentation), focused attention is provided for examples that have been implemented using high performance thin layer chromatographic techniques.

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“…Publication of such applications should serve as an example for others active in these areas. Highly cited applications are: the purity assessment of an active drug by HPLC-DAD [40], analysis of excipients by NIRA [41,42], classification of pharmaceutical substances [43], on-line monitoring of blending by NIRA [44], CZE method validation for the separation of inflammatory drugs [45], Classification and regression trees-studies (CART) of HIV reverse transcriptase inhibitors [46], classification of clinical study lots of a dermatological cream [47,48], on-line detection of the end point of a polymorph conversion reaction by near infrared spectroscopy (NIR) [49], application of three-way PCA in food analysis [50], optimization of a FIA method for glycine [51], and an inter-laboratory study of the determination of tylosin by HPLC [52].…”

Section: Demonstrate New Knowledge In Practicementioning

confidence: 99%

ChemoAC: its contribution to the advancement of Chemometrics

Vandeginste¹,

Smeyers‐Verbeke²

2007

Journal of Chemometrics

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Interlaboratory studies on two high-performance liquid chromatographic assays for tylosin (tartrate)

Cited by 21 publications

References 3 publications

Interlaboratory study of a NACE method for the determination of R‐timolol content in S‐timolol maleate: Assessment of uncertainty

Interlaboratory study of a NACE method for the determination of R‐timolol content in S‐timolol maleate: Assessment of uncertainty

Method Validation Approaches for Pharmaceutical Assessments – Highlights with High Performance Thin Layer Chromatographic (HPTLC) Techniques

ChemoAC: its contribution to the advancement of Chemometrics

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