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The manuscript presents a case study for the analysis of Filgrastim. The manuscript can be accepted for publication after some modification.

Posted by Dr. Zidan AS on 16 Feb 2011 03:51:49 PM GMT

1	Is the subject of the article within the scope of the subject category?	Yes
2	Are the interpretations / conclusions sound and justified by the data?	Partly
3	Is this a new and original contribution?	Yes
4	Does this paper exemplify an awareness of other research on the topic?	Yes
5	Are structure and length satisfactory?	No
6	Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience?	Yes
7	Can you suggest any reductions in the paper, or deletions of parts?	No
8	Is the quality of the diction satisfactory?	Yes
9	Are the illustrations and tables necessary and acceptable?	No
10	Are the references adequate and are they all necessary?	No
11	Are the keywords and abstract or summary informative?	Yes

Other Comments:
1. The authors did not specify the particle size of the silica in the stationary phase.

2. The authors did not specify the ICH guidelines, ICH Q8 or what?

3. The manuscript did not show any tables or figures.

4. The references are not shown in the manuscript.

5. State the equation for the LOD and LOQ calculations. At which signal to noise did the authors use for their calculations?

6. The authors did not test the interferences from other proteins. Also, the detection of the degradation products are not specified in the mansucript.

7. Specify the city and country for Roche products.

8. Cite a reference for the oxidation pathway of the drug.

9. The results and discussion needs to be fortified regarding the method develoment and optimization.
Competing interests:
No
Invited by the author to review this article? :
No
Have you previously published on this or a similar topic?:
Yes
References:
Int J Pharm. 2007 Aug 16;341(1-2):189-94. Epub 2007 Apr 21. J Pharm Sci. 2007 Sep;96(9):2409-23. J Pharm Sci. 2010 Mar;99(3):1180-92. Int J Pharm. 2010 Apr 15;389(1-2):186-94. Epub 2009 Dec 29.
Experience and credentials in the specific area of science:

I have developed different analytical method according to the ICH guidlines for different protein formulations including cyclosporine A and monoclonal antibodies. I have used RP HPLC, GC-MS and LC-MS techniques for the analysis of different small molecules.
How to cite: AS Z .The manuscript presents a case study for the analysis of Filgrastim. The manuscript can be accepted for publication after some modification.[Review of the article 'New High Performance Liquid Chromatography Method For Analysis Of Filgrastim In Pharmaceutical Formulations ' by Trajkovic-Jolevska S].WebmedCentral 2011;2(2):WMCRW00478

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Review - Filgrastim, HPLC

Posted by Prof. Jelena Cvejic on 10 Feb 2011 04:31:32 PM GMT

1	Is the subject of the article within the scope of the subject category?	Yes
2	Are the interpretations / conclusions sound and justified by the data?	Yes
3	Is this a new and original contribution?	Yes
4	Does this paper exemplify an awareness of other research on the topic?	Yes
5	Are structure and length satisfactory?	Yes
6	Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience?	No
7	Can you suggest any reductions in the paper, or deletions of parts?	No
8	Is the quality of the diction satisfactory?	Yes
9	Are the illustrations and tables necessary and acceptable?	Yes
10	Are the references adequate and are they all necessary?	Yes
11	Are the keywords and abstract or summary informative?	Yes

Other Comments:
In the present manuscript, the authors developed and validated a HPLC method for determination of filgrastim in protein formulations. the The objective of the study is clearly stated. The study has been carried out and reported in a competent manner. The experimental plan is sound and data are in enough details presented.
The work provides some additional information concerning both, the determination of filgrastim in protein formulations and separation and detection of oxidized forms of filgrastim in the beginning of their formation.
Invited by the author to review this article? :
Yes
Have you previously published on this or a similar topic?:
No
References:
None
Experience and credentials in the specific area of science:

Exprience in HPLC analysis.
How to cite: Cvejic J .Review - Filgrastim, HPLC[Review of the article 'New High Performance Liquid Chromatography Method For Analysis Of Filgrastim In Pharmaceutical Formulations ' by Trajkovic-Jolevska S].WebmedCentral 2011;2(2):WMCRW00454

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