Environmental benign AQbD based estimation of ketoconazole and beclomethasone by RP-HPLC and multi-analytical UV spectrophotometric method

Kannaiah, Kanaka Parvathi; Sugumaran, Abimanyu

doi:10.1016/j.microc.2021.106968

Cited by 20 publications

(3 citation statements)

References 20 publications

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“…Test tablets are considered bioequivalent to Dostinex tablets and could be approved as a good substitute for the generic product. Estimation for the greenness of the proposed LC/MS/MS method AGREE approach is simple and reliable for the assessment of eco-friendly characters of the analytical method [19,21,[36][37][38][39][40][41][42][43]. The final greenness numerical value was 0.63 with a relatively pale green color inside the pictogram as demonstrated in Additional file 1: Fig.…”

Section: Results Of Pharmacokinetic Parametersmentioning

confidence: 96%

A validated LC–MS/MS method for analysis of Cabergoline in human plasma with its implementation in a bioequivalent study: investigation of method greenness

et al. 2022

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Cabergoline (CAB) is effective prolactin lowering drug. Evaluation of the bioequivalence for the new test product (0.5 mg CAB film-coated tablets) in Egypt is strongly needed for approval of the drug by the official health authority. Therefore, a highly sensitive and rapid (LC–MS/MS) method was validated for CAB analysis in human plasma. CAB was extracted from plasma via diethyl ether using Quetiapine (QUE) as an internal standard. Multiple reaction monitoring (MRM) in positive ion mode was used, m/z 452.3 → 381.2 for CAB and 384.2 → 253.1 for QUE. Separation was accomplished on a reversed-phase C18. FDA procedures for the bio-analytical method were followed. The method was used in the bioequivalence study to compare the test product (0.5 mg CAB) versus Dostinex tablets, on 24 healthy Egyptian volunteers. The total analysis time was 5.5 min for each sample which permits analysis of various samples per day. The linearity range was from 2.00 to 200.00 pg/mL for CAB. LOD and LOQ were found to be 0.5 and 1.6 pg/mL, respectively. The final greenness numerical value was 0.63 using AGREE tool. The results of pharmacokinetic parameter Tmax were 2.17, and 2.33 h; for test and reference products, respectively. The generic formulation of test product is considered bioequivalent to the reference product Dostinex 0.5 mg tablets and satisfies the requirements of the Egyptian market. The merits of the method over the previous published methods are low cost; availability of cheap internal standard; rapidness; use of acetonitrile-free solvents mobile phase.

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Section: Results Of Pharmacokinetic Parametersmentioning

confidence: 96%

A validated LC–MS/MS method for analysis of Cabergoline in human plasma with its implementation in a bioequivalent study: investigation of method greenness

et al. 2022

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“…AGREE and GAPI analytical greenness approaches are dependable, simple and automated tools for evaluating an analytical method’s greenness (Chanduluru & Sugumaran, 2022; Gamal, Naguib, Panda, & Abdallah, 2021; Kannaiah & Sugumaran, 2022; Pena‐Pereira et al, 2020; Płotka‐Wasylka, 2018; Płotka‐Wasylka & Wojnowski, 2021; Sajid & Płotka‐Wasylka, 2022; Wojnowski et al, 2022). The overall AGREE score of 0.63 in Figure 5 denotes the satisfactory eco‐friendliness of the proposed method.…”

Section: Resultsmentioning

confidence: 99%

LC–MS/MS approach for simultaneous assessment of hyoscine N‐butyl bromide and ketoprofen in biological fluids and pharmaceuticals

Ali

Alsohaimi

Hasanin

et al. 2023

Biomedical Chromatography

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“…A design of experiment-based robustness study was performed to determine the probability of risk or failure [29][30][31][32][33][34][35][36][37][38][39][40][41][42]. The critical analytical attributes (CAAs) are selected from the finalized method conditions, which significantly impact the separation of components, and verified against respective critical quality attributes (CQAs).…”

Section: Design Of Experiments Studymentioning

confidence: 99%

Development, stability‐indicating assessment, and evaluation of influential method conditions using a full factorial design for the determination of Nintedanib esylate‐related impurities

Yenda

Katari

Satheesh³

et al. 2023

J of Separation Science

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The design of an appropriate analytical method for assessing the quality of pharmaceuticals requires a deep understanding of science, and risk evaluation approaches are appreciated. The current study discusses how a related substance method was developed for Nintedanib esylate. The best possible separation between the critical peak pairs was achieved using an X-Select charged surface hybrid Phenyl Hexyl (150 × 4.6) mm, 3.5 μm column. A mixture of water, acetonitrile, and methanol in mobile phase-A (70:20:10) and mobile phase-B (20:70:10), with 0.1% trifluoroacetic acid and 0.05% formic acid in both eluents. The set flow rate, wavelength, and injection volumes were 1.0 ml/min, 285 nm, and 5 μl, respectively, with gradient elution. The method conditions were validated as per regulatory requirements and United States Pharmacopeia general chapter < 1225 >. The correlation coefficient for all impurities from the linearity experiment was found to be > 0.999. The % relative standard deviation from the precision experiments ranged from 0.4 to 3.6. The mean %recovery from the accuracy study ranged from 92.5 to 106.5. Demonstrated the power of the stabilityindicating method through degradation studies; the active drug component is more vulnerable to oxidation than other conditions. Final method conditions were further evaluated using a full-factorial design. The robust method conditions were identified using the graphical optimization from the design space.

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Environmental benign AQbD based estimation of ketoconazole and beclomethasone by RP-HPLC and multi-analytical UV spectrophotometric method

Cited by 20 publications

References 20 publications

A validated LC–MS/MS method for analysis of Cabergoline in human plasma with its implementation in a bioequivalent study: investigation of method greenness

A validated LC–MS/MS method for analysis of Cabergoline in human plasma with its implementation in a bioequivalent study: investigation of method greenness

LC–MS/MS approach for simultaneous assessment of hyoscine N‐butyl bromide and ketoprofen in biological fluids and pharmaceuticals

Development, stability‐indicating assessment, and evaluation of influential method conditions using a full factorial design for the determination of Nintedanib esylate‐related impurities

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