A Review on Revision of ICH Q2 (R1) and New ICH Q14 Guidance

Chaursiya, Ajay C.; Dumpala, Rajesh L.

doi:10.47583/gjfpas.2020.v01i06.001

Cited by 26 publications

(6 citation statements)

References 1 publication

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“…The linearity demonstrated the linear dependence of the analytical signal from the concentration of the analyte within the analytical area of the method [ 19 ]. For the calibration curve, the correlation coefficient (R 2 ) must be above 0.99 to be acceptable.…”

Section: Resultsmentioning

confidence: 99%

Development of Hyphenated Techniques and Network Identification Approaches for Biotransformational Evaluation of Promising Antitubercular N-pyrrolyl hydrazide-hydrazone in Isolated Rat Hepatocytes

et al. 2023

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Novel, rapid and precise RP-HPLC–DAD method was developed, validated and successfully applied for determination of metabolic changes of ethyl 5-(4-bromophenyl)-1-(3-(2-(2-hydroxybenzylidene)hydrazinyl)-3-oxopropyl)-2-methyl-1 H -pyrrole-3-carboxylate ( 12b ) in isolated rat hepatocytes. The analytes were detected by a simple DAD detector at 279 nm wavelength. A single-step extraction method was implemented to enable fast purification and extraction from cellular culture, resulting in a complete recovery. Thereafter, the method was adequately transferred to a LC–MS system for identification of unknown products. Additionally, network metabolism evaluation was performed to predict the structures of major metabolites with their isotope mass through BioTransformer 3.0. The data from the LC–MS analysis and the online server were compared for comprehensive identification. The results indicated formation of four metabolic products, obtained through processes of hydrolysis ( 12 and b ), hydroxylation in the structure 12b ( M1 ) and O-dealkylation ( M2 ).

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Section: Resultsmentioning

confidence: 99%

Development of Hyphenated Techniques and Network Identification Approaches for Biotransformational Evaluation of Promising Antitubercular N-pyrrolyl hydrazide-hydrazone in Isolated Rat Hepatocytes

et al. 2023

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“…The result obtained for different wavelength data for AZA and CAM Precision Two levels of precision were examined: repeatability (daily) and intermediate precision (inter-day). The findings are shown in %RSD (as shown inTable 5,6), which stayed below 2% and demonstrated the exceptional precision of this technique.…”

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confidence: 78%

“…5 Neem has a wide range of triterpenoids, in addition to AZA, including nimbin, salannin, azadirachtol, nimbidinin, and gedunin. 6 Figure 1 depicts the structure of AZA.The wood of the camphor laurel (Cinnamomum camphora) and other similar plants of the laurel family is the source of camphor, a white, crystalline chemical with a strong aroma and bitter taste. Wood, twigs, and tree bark are processed through steam distillation, filtration, and sublimation to produce camphor.…”

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confidence: 99%

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Development and Validation of an Analytical Method for the Simultaneous Estimation of Azadirachtin and Camphor in a New Herbal Formulation

Khristi¹,

Patel²,

Wagh³

2022

IJPQA

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Background: High-performance liquid chromatography (HPLC) is an analytical tool for determining the quality of a drug product. Separating, identifying, and quantifying the various drugs should be able to HPLC methods. To quantify azadirachtin and camphor, a novel HPLC technique was created that is sensitive and selective. Objective: The analysis of azadirachtin and camphor has been designed and verified using a simple, efficient, selective, and precise HPLC technique. Material and Method: With the help of an HPLC C18 column (4.6 x 250 mm, 5 m), a mobile phase made up of buffer (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile in the ratio 15:85, flow rate of 1.0 mL/min, and column temperature kept at 35°C, good chromatographic separation was achieved in the current study. The resulting effluents were seen at 294 nm using a UV-visible detector. Result and Discussion: Sharp peaks for azadirachtin and camphor were found at retention times of 3.5 and 4.8 minutes, respectively, during the detection process at 294 nm. Over the concentration ranges of 0.1–0.9 g/mL for azadirachtin and 20–180 g/mL for camphor, the calibration curve was linear. According to International Council on Harmonisation (ICH) guidelines, the method was verified for accuracy, precision, repeatability, specificity, robustness, and detection and quantification limits. Conclusion: The proposed method has specificity, accuracy, and sensitivity, with an excellent linear.

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Separation and Characterization of New Forced Degradation Products of Dasatinib in Tablet Dosage Formulation Using LC–MS and Stability-Indicating HPLC Methods

Lakka

Kuppan

Srinivas³

et al. 2020

Chromatographia

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A Review on Revision of ICH Q2 (R1) and New ICH Q14 Guidance

Cited by 26 publications

References 1 publication

Development of Hyphenated Techniques and Network Identification Approaches for Biotransformational Evaluation of Promising Antitubercular N-pyrrolyl hydrazide-hydrazone in Isolated Rat Hepatocytes

Development of Hyphenated Techniques and Network Identification Approaches for Biotransformational Evaluation of Promising Antitubercular N-pyrrolyl hydrazide-hydrazone in Isolated Rat Hepatocytes

Development and Validation of an Analytical Method for the Simultaneous Estimation of Azadirachtin and Camphor in a New Herbal Formulation

Separation and Characterization of New Forced Degradation Products of Dasatinib in Tablet Dosage Formulation Using LC–MS and Stability-Indicating HPLC Methods

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