Theoretical repeatability assessment without repetitive measurements in gradient high-performance liquid chromatography

Kotani, Akio; Tsutsumi, Risa; Shoji, Asaki; Hayashi, Yuzuru; Kusu, Fumiyo; Yamamoto, Kazuhiro; Hakamata, Hideki

doi:10.1016/j.chroma.2016.05.065

Cited by 4 publications

(5 citation statements)

References 14 publications

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“…For determining the three parameters, w , m , and ρ, the consecutive baseline noise data of 2 n (2 to the nth power) points were transformed into the real power spectrum by the Fourier transform, and then the theoretical power spectrum (P( f ), Eq. 1) was least-squares fitted to the observed power spectrum [22][23][24][25] :…”

Section: Resultsmentioning

confidence: 99%

“…The power spectrum has the common natural phenomena feature where the power spectrum densities at low frequencies are larger than those at high frequencies. [22][23][24][25] It is often called 1/f fluctuation. And, based on the Eq.…”

Section: Resultsmentioning

confidence: 99%

“…In the ISO 11843-7, S B in the integration domain (k e ) was obtained by Eq. 2 which consisted of three noise parameters, w , m , and ρ, as follows [22][23][24][25] :…”

Section: Estimation Of Sd Of Baseline Noise and Rsd Of Peak Area Prmentioning

confidence: 99%

“…and the RSD without repetitive measurements of real samples, it has utilized chromatographic baseline noise in most of the HPLC and GC systems that exhibited flicker noise (or 1/f fluctuation), [18][19][20][21][22][23] and chromatographic baseline noise is approximated by a mixed well-defined stochastic process of white noise and Markov process using power spectrum analysis. 24) If the baseline noise in SFC with electrochemical detection (SFC-ECD) corresponds to the stochastic process, the RSD of the peak area can be obtained without repetitive measurements by ISO 11843-7. However, it has not been clarified whether the baseline noise in SFC-ECD can also be dealt with in a similar way when repeatability assessments in HPLC methods are performed.…”

Section: Introductionmentioning

confidence: 99%

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Assessment of Repeatability in Supercritical Fluid Chromatography with Electrochemical Detection Based on the ISO 11843 Part 7

Yamamoto

Kotani

Hayashi³

et al. 2019

CHEMICAL & PHARMACEUTICAL BULLETIN

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The present study proposes a method for the assessment of repeatability in supercritical fluid chromatography with electrochemical detection (SFC-ECD), based on the ISO 11843 part 7 (ISO 11843-7:2018) which can theoretically provide detection limits and standard deviation (S.D.) through the stochastic properties of baseline noise without repetitive measurements of real samples. On the baseline noise of SFC-ECD, large-amplitude and periodic noises with less than 0.05 Hz were observed, and the power spectrum of the baseline noise showed 1/f fluctuation ( f frequency). It was found that the present power spectrum analysis, according to the law of error propagation, can provide suitable noise parameters to calculate S.D. of baseline noise and a relative S.D. (RSD) of peak area by ISO 11843-7. The chromatographic determinations of α-, β-, γ-and δ-tocopherol have been taken as examples. In the present SFC-ECD, the RSDs of peak areas for α-, β-, γ-and δ-tocopherol obtained by ISO 11843-7 were within 95% confidence intervals of the RSD of them obtained by repetitive measurements (n 6). Thus, we found that ISO 11843-7 is applicable to the assessment of repeatability in SFC-ECD for determining tocopherols without repetitive measurements.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…In the ISO 11843-7, S B in the integration domain (k e ) was obtained by Eq. 2 which consisted of three noise parameters, w , m , and ρ, as follows [22][23][24][25] :…”

Section: Estimation Of Sd Of Baseline Noise and Rsd Of Peak Area Prmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Assessment of Repeatability in Supercritical Fluid Chromatography with Electrochemical Detection Based on the ISO 11843 Part 7

Yamamoto

Kotani

Hayashi³

et al. 2019

CHEMICAL & PHARMACEUTICAL BULLETIN

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show abstract

“…Also, the measurement RSD of stochastic ways by ISO 11843-7 had 95% confidence intervals corresponding to those for about 40 measurements (±20% of the true RSD). 18 Although ISO 11843-7 has been recently applied to examine the detection limits and predict measurement precision in HPLC-ECD for synthetic drugs, 19 the other application of ISO 11843-7 has hardly been reported to obtain an allowable limit of the "System repeatability" in quantitative HPLC-UV for herbal medicines, and to estimate the repeatability in LC with multi-channel detections, such as LC-3ECD. If ISO 11843-7 is applied to estimate the measurement precision in quantitative HPLC-UV and LC-3ECD of herbal medicines, the number of chromatographic measurements would be one without reducing the reliability of the measurement RSD.…”

Section: Introductionmentioning

confidence: 99%

Repeatability Assessment by ISO 11843-7 in Quantitative HPLC for Herbal Medicines

et al. 2015

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We have proposed an assessment methods to estimate the measurement relative standard deviation (RSD) of chromatographic peaks in quantitative HPLC for herbal medicines by the methodology of ISO 11843 Part 7 (ISO 11843-7:2012), which provides detection limits stochastically. In quantitative HPLC with UV detection (HPLC-UV) of Scutellaria Radix for the determination of baicalin, the measurement RSD of baicalin by ISO 11843-7:2012 stochastically was within a 95% confidence interval of the statistically obtained RSD by repetitive measurements (n = 6). Thus, our findings show that it is applicable for estimating of the repeatability of HPLC-UV for determining baicalin without repeated measurements. In addition, the allowable limit of the "System repeatability" in "Liquid Chromatography" regulated in a pharmacopoeia can be obtained by the present assessment method. Moreover, the present assessment method was also successfully applied to estimate the measurement RSDs of quantitative three-channel liquid chromatography with electrochemical detection (LC-3ECD) of Chrysanthemi Flos for determining caffeoylquinic acids and flavonoids. By the present repeatability assessment method, reliable measurement RSD was obtained stochastically, and the experimental time was remarkably reduced.

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An automated system for predicting detection limit and precision profile from a chromatogram

Kotani

Tsugu

Hakamata

et al. 2020

Journal of Chromatography A

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Theoretical repeatability assessment without repetitive measurements in gradient high-performance liquid chromatography

Cited by 4 publications

References 14 publications

Assessment of Repeatability in Supercritical Fluid Chromatography with Electrochemical Detection Based on the ISO 11843 Part 7

Assessment of Repeatability in Supercritical Fluid Chromatography with Electrochemical Detection Based on the ISO 11843 Part 7

Repeatability Assessment by ISO 11843-7 in Quantitative HPLC for Herbal Medicines

An automated system for predicting detection limit and precision profile from a chromatogram

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