E-ISSN 0976-2779 | ISSN 0975-8453
 

Review Article 


Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali.

Abstract
Introduction: The paper presents analytical methods for the identification of Roseofungin active pharmaceutical ingredient (API) using thin layer chromatography (TLC) and spectrophotometry in the ultraviolet region, for the drug CANPROFEM - AK containing the original polyene antibiotic Roseofungin in the form of suppositories. The study established optimal conditions for the experiment, including sample preparation; the Specificity validation characteristic was examined for each method.
Results: Method 1 employed the TLC plate pre-coated with a layer of F254 silica gel using n-butanol saturated with purified water as a mobile phase; the substance was identified in UV light at a wavelength of 365 nm. The method makes it possible to uniquely and specifically identify roseofungin in the presence of placebo components.
In method 2, the maximum of the ultraviolet absorption spectrum of the solution being tested coincides with the maximum of theultraviolet absorption spectrum of the reference sample solution (3642 nm).
Conclusion: The methods are suitable for solving the intended objectives and are included in the draft analytical normative document on the finished product quality control by the Identification characteristic.

Key words: roseofungin, CANPROFEM-AK suppositories, thin-layer chromatography, absorption spectrophotometry in the ultraviolet and visible regions, validation, identification.


 
ARTICLE TOOLS
Abstract
PDF Fulltext
How to cite this articleHow to cite this article
Citation Tools
Related Records
 Articles by L.N. Ibragimova
Articles by A.S. Balgimbaeva
Articles by A.K. Sadanov
Articles by Z.B. Sakipova
Articles by G.E. Tugelbay
Articles by A.Kh. Khasenova
Articles by Z. Turlybayeva
Articles by L.P. Trenozhnikova
Articles by I.I. Terninko
Articles by E.N. Bekbolatova
Articles by A.K. Yergali
on Google
on Google Scholar


How to Cite this Article
Pubmed Style

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali. Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic. SRP. 2020; 11(5): 01-09. doi:10.31838/srp.2020.5.01


Web Style

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali. Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic. http://www.sysrevpharm.org//?mno=106518 [Access: May 31, 2020]. doi:10.31838/srp.2020.5.01


AMA (American Medical Association) Style

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali. Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic. SRP. 2020; 11(5): 01-09. doi:10.31838/srp.2020.5.01



Vancouver/ICMJE Style

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali. Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic. SRP. (2020), [cited May 31, 2020]; 11(5): 01-09. doi:10.31838/srp.2020.5.01



Harvard Style

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali (2020) Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic. SRP, 11 (5), 01-09. doi:10.31838/srp.2020.5.01



Turabian Style

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali. 2020. Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic. Systematic Reviews in Pharmacy, 11 (5), 01-09. doi:10.31838/srp.2020.5.01



Chicago Style

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali. "Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic." Systematic Reviews in Pharmacy 11 (2020), 01-09. doi:10.31838/srp.2020.5.01



MLA (The Modern Language Association) Style

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali. "Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic." Systematic Reviews in Pharmacy 11.5 (2020), 01-09. Print. doi:10.31838/srp.2020.5.01



APA (American Psychological Association) Style

L.N. Ibragimova, A.S. Balgimbaeva, A.K. Sadanov, Z.B. Sakipova, G.E. Tugelbay, A.Kh. Khasenova, Z. Turlybayeva, L.P. Trenozhnikova, I.I. Terninko, E.N. Bekbolatova, A.K. Yergali (2020) Development and Validation of Analytical Methods for the Identification in Canprophem - АK Suppositories with the New Original Polyene Antibiotic. Systematic Reviews in Pharmacy, 11 (5), 01-09. doi:10.31838/srp.2020.5.01