Ecofriendly, Simple, Fast and Sensitive UPLC-MS/MS Method for Determination of Erdafitinib, a Novel Tyrosine Kinase Inhibitor, in Plasma and Its Application to Metabolic Stability
, Gamal A. Mostafa 1, Mohamed R. Alhazani 1 and Yousif A. Asiri 2Round 1
Reviewer 1 Report
In this manuscript of "Ecofriendly, Simple, Fast and sensitive UPLC-MS/MS method for determination of Erdafitinib, a novel tyrosine kinase inhibitor, in plasma and its application to metabolic stability", the authors developed and validated a specific, and precise UPLC–MS/MS method for determination of Erdafitinib (ERDA) in plasma samples. From this method, the calibration curve was built in the range of 0.5-1000.0 ng/mL, while the low limit of quantitation reach 1.0 ng/mL. The greenness of this method is excellent by evaluating of appropriate analytical Eco-Scale and AGREE software. Overall, this method is suitable for high throughput analysis of metabolic stability of Erdafitinib.
However, the following concerns should be addressed for further publishing consideration.
1. Please provide enough explanation about the abbreviations through the manuscript, such as IS and TBM in abstract, PPT in Table 5. Hopefully, it will help the readers much easier to understand.
2. In Figure 1, it should be better to illustrate the structure of ibrutinib (IS) as an important internal standard in this manuscript.
3. Please present the discussion about Table 5 for comparison of the current method with previous reported methods for The determination of ERDA in plasma samples.
4. The separation retention time of Current method in Table 5 should be 1.2 min from Figure 3.
5. In line 313, the equation of the Linear part of the curve should be y = -0.0951x + 4.6188.
6. In line 314, the half-life (t1/2) is 7.28 min with time unit.
7. In line 331, it should be 0.78 for the AGREE pictogram score from Figure 5, but not 0.77.
Author Response
Response to Review 1
Reviewer: Please provide enough explanation about the abbreviations through the manuscript, such as IS and TBM in abstract, PPT in Table 5. Hopefully, it will help the readers much easier to understand.
Response: abbreviations has been explained.
Reviewer: In Figure 1, it should be better to illustrate the structure of ibrutinib (IS) as an important internal standard in this manuscript.
Response: structure of ibrutinib has been illustrated
Reviewer: Please present the discussion about Table 5 for comparison of the current method with previous reported methods for The determination of ERDA in plasma samples.
Response: difference of the current method with previous method has been added in paragraph 2.5.9.
Reviewer: The separation retention time of Current method in Table 5 should be 1.2 min from Figure 3.
Response: The separation retention time has been corrected.
Reviewer: In line 313, the equation of the Linear part of the curve should be y = -0.0951x + 4.6188
Response: The equation has been corrected
Reviewer 2 Report
The article, Eco-friendly, simple, fast, and sensitive UPLC-MS/MS method for determining Erdafitinib, a novel tyrosine kinase inhibitor in plasma and its application to metabolic stability, by Ali et al., is written well and the developed method was validated thoroughly. Also, to demonstrate its application to real plasma samples, this study compared the sensitivity of the method with those of existing methods. The manuscript is acceptable for publication after a few minor revisions.
The following revisions are required to improve the clarity of the article.
1. Section 2.1. Instrumentation and Analytical Conditions
Although the authors described an isocratic chromatography method for separating a target analyte and an internal standard, they did not mention the total run time used for analysis. Please include this information.
Revise the Table 1. Under this section
Provide target analyte and IS retention time (Rt)
Precursor ion (m/z)….
Product Ion (m/z)…
Collision energy (eV)…
Nitrogen flow (L/h)….
2. Correct mass ion labels in figure 2.
m/z 447.2 and 441.1 (precursor ions)
m/z 86.0 and 84.0 (product ions)
Represent ion unit as m/z
Author Response
Response to review 2
Reviewer: Although the authors described an isocratic chromatography method for separating a target analyte and an internal standard, they did not mention the total run time used for analysis. Please include this information.
Response: Separation time of each of analyr and internal standard and total run time has been added
Reviewer: Revise the Table 1.
Response: The table has been revise according to the reviewer comments.
Reviewer: Correct mass ion labels in figure 2.
Response: Mass ion has been corrected
Round 2
Reviewer 1 Report
The authors have done all the necessary correction and now the manuscript could be accepted in this current version.
