Fast Screening Methods for the Analysis of Topical Drug Products
Round 1
Reviewer 1 Report
Line-24, 50,53,103 : Full form of the abbreviations.
Line 107, 121, 158, 212, 24, 261, 262, 322, 337 :Correct the reference errors.
Line 163, 171, 334, 345: Keep consistency in reference style.
Table-7: ETF 175.0 ±4, is this correct?
Table-9: ETF 198.0 ±5, & DF: 179.73 ±4, is this correct?
Section 2.2: Missing details- temperature, elution technique, sample preparation.
Table-2: Describe the basis of the selection of release media and its composition.
Conclusion: Not convincing. Please rewrite.
All the tables: Consistency in significant numbers/decimals is needed.
Overall: Chromatograms for each drug (Sample and Standard) are needed to judge the work fairly. Introduction and discussion need revision in writing to convey the aims and accomplishments. Reference error correction and reference style consistency is required. There are several grammatical errors, good proofreading is recommended.
Author Response
Please see the attachment.
Author Response File: 
Author Response.pdf
Reviewer 2 Report
The study is interesting and with a lot of data. However, in the literature there are various papers that report the validation of HPLC analytical methods for the evaluation of active substances. The authors must highlight in the manuscript the novelty of their study compared to those present in the literature.
In the abstract the authors claim they studied "eight topical complex drug products". what do they mean by complex? It is just creams or gels.
Did the authors check the stability of the formulations during the in vitro release test? How?
Author Response
Please see the attachment.
Author Response File: Author Response.pdf
Reviewer 3 Report
The authors described the validation parameter in a well organised way. There are some questions need to be addressed. These questions necessitate a revision to this manuscript before it could be considered for acceptance.
Firstly, the authors did the permeation studies using artificial membrane. Can you please justify the reason?
Next, the permeation release study were conducted at 37 degree celcius. Can you please justify the reason? Skin surface temperature is 32 degree celcius.
In addition, most of the drugs tested here do not need systemic effect. But authors focus on permeation release study rather than mass balance studies. Can you please justify that? The mass balance methods need to be described.
Author Response
Please see the attachment.
Author Response File: Author Response.pdf
Round 2
Reviewer 1 Report
Line 163, 172, 332, 436, 446: Keep consistency in reference style.
Line 116: 10 mg of drug in 10 mL of what?
Line 139: Please correct the order of terms (specificity, linearity, accuracy, precision, etc.) in this line or correct the order of appearance these terms in the next sections.
Line 175: Please separate the equation from the paragraph and mention it as an equation -XX.
Line 243: Please number the equation.
Table 7: what is CQ?
Table 7: Please mention % RSD.
Line 446: Please correct the figure number.
Line 120 and Table 2: Acyclovir stock solution was prepared in water, but the release media used was PBS. Please can you justify this?
Figure 1 and Table 4: Please arrange chromatograms to match the order of drugs in table 4. Also, it could be simpler to understand the point if there is a table of standard and sample retention time.
Figure 1: Tioconazole chromatogram doesn’t match with claimed retention time. Please justify or correct it?
Figure 1: In some chromatograph, there are multiple peaks of standard and samples. If the overlapping peaks are samples and standards then what are other peaks indicating?
Overall:
The revised version is better than previous but overall presentations can be improved. The sample and standard preparation are still not clear yet (e.g. was the release media with/without drug was injected directly or further dilution was made before injection?)
Author Response
Please see attachment.
Author Response File: Author Response.pdf
Round 3
Reviewer 1 Report
Line 161, 170, 349, 456, 466: Keep consistency in reference style.
Table 8: Please either mention ‘Concentration QC’ or ‘Initial concentration’. Please mention units too.
Tables 9 and 10: Follow the above guideline in these two tables.
Missing reference in the text: 41, 42.
Referencing is still inappropriate. The numbered reference should follow the order.
Overall:
The manuscript has been revised and looks better than the previous version. However, there are repeated mistakes in referencing. The total number of references doesn’t match with reference numbers in the text of the manuscript.
Author Response
Please see the attachment
Author Response File: Author Response.pdf
