Evaluation Excipients and pH Effects on Impurity of Desloratadine Syrup Formulation
Evaluation Excipients and pH Effects on Impurity of Desloratadine Syrup Formulation
The goal of the research work was to compare the excipient and pH effect develop a stabile pharmaceutical product which is Desloratadine syrup. A total of seven formulations were prepared and syrup to stability study. This study is used different excipients and is tried pH for improve product. To improve the stability of Desloratadine formulations (F1-F7) were evaluated with different excipients and pH during stability period. Stability studies were performed to evaluate impurity and assay of desloratine. The rate of initial and 6th months impurity results were compared to F1-F7 formulations. As a result of initial, 3rd and 6th months impurity analysis for F7 formulations were found to be within in limit. According to the evaluation results, the F-7 formulation was chosen as the stabilize and best formulation. Those results showed that the F-7 formulation was stable in the stability studies. Both of them were determined to the best formulations about impurity and pH of desloratadine.
Keywords:
Drug formulation, Desloratadine, syrup, excipient, pH, stability study, impurity HPLC,
___
- https://www.researchgate.net/publication/298649069_Formulation_development_and_evaluation_of_desloratadine_tabletsDrug Bank showing Desloratidine (DB00967)
- https://sphinxsai.com/july-sept_2010_vol2.3/pharmtech/pharmtechvol2.3july-sept210/PT=70%20(2101-2106).pdf
- Raymond C.R, Paul J.S and Sian C.O, Pharmaceutical Excipients, 255-256.
- https://patents.google.com/patent/CN101390860A/en
- https://patents.google.com/patent/CN104784110A/en
- ICH Guideline, “Validation of analytical procedures: text and methodology,” in Proceedings of International Conference on Harmonization, Topic Q2 (R1), Geneva, Switzerland.
- https://www.ema.europa.eu/en/documents/variation-report/aerius-h-c-313-x-0033-epar- assessment-report-extension_en.pdf
- https://www.ema.europa.eu/en/documents/variation-report/aerius-h-c-313-x-0033-epar- assessment-report-extension_en.pdf
- Development and validation of a novel revesed phase high performance liquid cromatograpy with refractive index detector method for assay of polyvinyl alcohol in an ophthalmic solution.current pharmaceutical analysis 2020
- Raymond C.R, Paul J.S and Sian C.O, Pharmaceutical Excipients, 301-303.
- Raymond C.R, Paul J.S and Sian C.O, Pharmaceutical Excipients, 185-187.
- https://pubchem.ncbi.nlm.nih.gov/compound/Desloratadine
- https://go.gale.com/ps/i.do?id=GALE%7CA252944814&sid=googleScholar&v=2.1&it=r&linkaccess=abs&issn=19950772&p=AONE&sw=w&userGroupName=anon%7E6be0a7bb
- Başlangıç: 2021
- Yayıncı: Atatürk Üniversitesi
Sayıdaki Diğer Makaleler
Süleyman ÇETİN, Yaşar Furkan KILINBOZ, Afife Büşra UĞUR KAPLAN, Meltem ÇETİN
Evaluation Excipients and pH Effects on Impurity of Desloratadine Syrup Formulation
IN VITRO CYTOTOXICITY TEST METHODS: MTT and NRU
Fatih BAYGUTALP, Nurcan KILIÇ BAYGUTALP, Faruk URAK, Abdulbaki BİLGİC