Development of Stability Indicating HPLC–UV Method for Determination of Daclatasvir and Characterization of Forced Degradation Products
| العنوان: | Development of Stability Indicating HPLC–UV Method for Determination of Daclatasvir and Characterization of Forced Degradation Products |
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| المؤلفون: | Waseem Hassan, Bakht Zaman |
| المصدر: | Chromatographia. 81:785-797 |
| بيانات النشر: | Springer Science and Business Media LLC, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | 0301 basic medicine, Detection limit, Chromatography, Daclatasvir, Hydrochloride, 030106 microbiology, 010401 analytical chemistry, Organic Chemistry, Clinical Biochemistry, 01 natural sciences, Biochemistry, High-performance liquid chromatography, Dosage form, 0104 chemical sciences, Analytical Chemistry, 03 medical and health sciences, chemistry.chemical_compound, chemistry, Potassium phosphate, Forced degradation, medicine, Acetonitrile, medicine.drug |
| الوصف: | A simple and sensitive stability indicating high performance liquid chromatography method was developed for quantification of Daclatasvir hydrochloride in bulk and tablet dosage forms. The analysis was performed on water symmetry analytical column (150 mm × 3.9 mm, 5 µm), packing octyl silica (Si-[CH2]7-CH3) C8. Mobile phase containing potassium phosphate buffer (pH 2.0) and acetonitrile (38: 62) v/v was used at flow rate 0.7 mL min−1 for isocratic elution. Detection was performed on 304 nm using UV detector. The method was validated appropriately according to the requirements of United State Pharmacopeia and International Conference on Harmonization guideline Q2 (R1). Recovery, precision, linearity and specificity of the method were assured. The correlation coefficient for linearity ranged from 2 to 24 µg mL−1 was (r > 0.9999). The limits of detection and quantification of Daclatasvir were 0.08 and 0.28 µg mL−1, respectively. Stability studies of Daclatasvir were performed under various stressed conditions, i.e., hydrolytic (acidic, basic and neutral), oxidation, photolytic and thermal conditions, according to International Conference on Harmonization Q1A (R2) and QIB Guidelines. The degradation products were resolved using proposed method and further characterized by MS, NMR and IR spectroscopic analyses. The proposed method was successfully applied to assay determination of bulk drugs and tablet dosage forms. |
| تدمد: | 1612-1112 0009-5893 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::208b84f8b6f41e063477f42bcf9b32dc https://doi.org/10.1007/s10337-018-3503-7 |
| حقوق: | CLOSED |
| رقم الأكسشن: | edsair.doi...........208b84f8b6f41e063477f42bcf9b32dc |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 16121112 00095893 |
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