International Council for Harmonisation (ICH) guidelines

Bhavna, Kumar; Ojha, Abhijeet; Bhargava, Samir

doi:10.1016/b978-0-12-822211-9.00008-3

Cited by 11 publications

(6 citation statements)

References 2 publications

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“…The developed HPLC method was validated according to the International Council on Harmonization (ICH) guidelines ( Bhavna et al, 2022 ). The calibration curve was linear over the concentration range of 2.5–78.0 μg/mL, with a correlation coefficient of more than 0.999.…”

Section: Resultsmentioning

confidence: 99%

A new cirrhotic animal protocol combining carbon tetrachloride with methotrexate to address limitations of the currently used chemical-induced models

et al. 2023

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Background: Chemically induced cirrhotic animal models are commonly used. However, they have limitations such as high mortalities and low yield of cirrhotic animals that limit their uses.Aims: To overcome limitations of the chemically induced cirrhotic animal model via combined administration of methotrexate (MTX) with CCl4 and decrease their commonly used doses depending on the proposed synergetic cirrhotic effect.Methods: Rats were divided into six groups: normal (4 weeks), normal (8 weeks), MTX, CCl4 (4 weeks), CCl4 (8 weeks), and MTX + CCl4 (4 weeks) groups. Animals’ hepatic morphology and histopathological characterization were explored. Hepatic Bcl2 and NF-κB-p65 tissue contents were determined using the immunostaining technique, and hepatic tissue damage, oxidative status, and inflammatory status biochemical parameters were determined.Results: CCl4 + MTX combined administration produced prominent cirrhotic liver changes, further confirmed by a substantial increase in oxidative stress and inflammatory parameters, whereas mortalities were significantly lower than in other treated groups.Conclusion: The present study introduced a new model that can significantly improve the major limitations of chemically induced cirrhotic animal models with new pathological features that mimic human cirrhosis. Compared to other chemically induced methods, the present model can save time, cost, and animal suffering.

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Section: Resultsmentioning

confidence: 99%

A new cirrhotic animal protocol combining carbon tetrachloride with methotrexate to address limitations of the currently used chemical-induced models

et al. 2023

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“…The trouble was identified using an Ishikawa fishbone diagram, which depicted all conceivable aspects that may affect the technique development. 10 The Critical Analyte Attribute (CAA) and variables involved in method development were identified as the first phase, and an Ishikawa fishbone diagram depicting the link between them was drawn (Figure 3). Following the study of the Ishikawa fishbone diagram, several technique factors such as sample/instrument scanning speed, solvent kinds, sampling interval, sample integrity, and so on were investigated.…”

Section: Assessment Of Riskmentioning

confidence: 99%

Implementation of Analytical Quality by Design Methodology to Develop a UV Spectrometric Technique for Arteether Quantification

Bajwa,

Saroch,

Baldi

2023

Ind. J. Pharm. Edu. Res.

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Aim/Background: Analytical Quality by Design refers to applying the Quality by Design idea to the development of analytical procedures. The present study emphasizes the AQbD concept of developing and validating a spectrophotometric technique for detecting α, β-arteether per the ICH Q8 (R 2 ) requirements for the first time. Materials and Methods: Sample preparation, sample pH, and wavelength were all integrated into the Ishikawa diagram, and essential parameters were obtained. The ratio of ethanolic PBS 6.8 and HCl was taken as factors. At the same time, the drug molecule's absorbance was identified as a critical factor that was further analyzed using a simple mixture design of experiments methodology for method robustness and optimization. The novel, durable, precise, and accurate UV-spectrophotometric method, α, β-arteether, was developed using the Quality by Design principle. By adjusting the HCl concentration (for acid degradation) and ethanolic PBS 6.8, the highest absorption of α, β-arteether was achieved by heating at 50°C for 30 min. Results and Discussion: The percent RSD less than 2, R 2 > 0.99 was recorded for the concentration range of 2-20 μg/mL at λ max 254 nm. The developed method's LOD and LOQ were within acceptable limits. The presented approach might be used at the industrial level as a rapid, precise, accurate, and cost-effective quality control method for a frequent and simultaneous estimate of α, β-arteether.

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“…The HPLC method was validated according to the International Conference on Harmonization (ICH-Q2(R1)) [25][26][27], with the results shown in Table 2. Piperenamide A was only found in samples of black betel ethanol extract with retention times of 3.968, 3.973, 3.959, 3.966, and 3.980 min.…”

Section: Quantitative Analysis Using High-performance Liquid Chromato...mentioning

confidence: 99%

“…The HPLC method was validated according to the International Conference monization (ICH-Q2(R1)) [25][26][27], with the results shown in Table 2. All validation data in Table 2 showed that the method meets the validation based on international standards.…”

Section: Quantitative Analysis Using High-performance Liquid Chromato...mentioning

confidence: 99%

Quality Control and Authentication of Black Betel Leaf Extract (Piper acre Blume) from East Kalimantan as an Antimicrobial Agent Using a Combination of High-Performance Liquid Chromatography and Chemometric Fourier Transform Infrared

et al. 2023

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Black betel leaf from East Kalimantan contains various secondary metabolites such as alkaloid saponins, flavonoids, and tannins. A compound, piperenamide A, which has antimicrobial activity, is also found in black betel leaf. This study aims to identify and authenticate the compound piperenamide A found in black betel leaf extract in other types of betel plant using HPLC and FTIR-chemometrics. The extraction method used was maceration with 70% ethanol solvent. Determination of piperenamide A content in black betel leaf extract was via HPLC column C18, with a maximum wavelength of 259 nm and a mobile phase of water:acetonitrile at a flow rate of 1 mL/minute. From the results, piperenamide A was only found in black betel (Piper acre) and not in Piper betel and Piper crocatum. Piperenamide A levels obtained were 4.03, 6.84, 5.35, 13.85, and 2.15%, respectively, in the samples studied. The combination of FTIR spectra with chemometric methods such as PCA and PLS-DA was used to distinguish the three types of betel. Discriminant analysis can classify black betel (Piper acre), Piper betel, and Piper crocatum according to its type. These methods can be used for identification and authentication of black betel.

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International Council for Harmonisation (ICH) guidelines

Cited by 11 publications

References 2 publications

A new cirrhotic animal protocol combining carbon tetrachloride with methotrexate to address limitations of the currently used chemical-induced models

A new cirrhotic animal protocol combining carbon tetrachloride with methotrexate to address limitations of the currently used chemical-induced models

Implementation of Analytical Quality by Design Methodology to Develop a UV Spectrometric Technique for Arteether Quantification

Quality Control and Authentication of Black Betel Leaf Extract (Piper acre Blume) from East Kalimantan as an Antimicrobial Agent Using a Combination of High-Performance Liquid Chromatography and Chemometric Fourier Transform Infrared

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