Validated spectroscopic methods for determination of anti-histaminic drug azelastine in pure form: Analytical application for quality control of its pharmaceutical preparations
| Autor: | Dalia R. El-Wasseef, Amal A. El-Masry, Mohammed E. A. Hammouda, Saadia M. El-Ashry |
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| Rok vydání: | 2018 |
| Předmět: |
Quality Control
Absorption (pharmacology) Time Factors Analytical chemistry 01 natural sciences Dosage form Analytical Chemistry Absorbance Surface-Active Agents chemistry.chemical_compound Limit of Detection Anti-Allergic Agents medicine Eosin Y Instrumentation Spectroscopy Dosage Forms Detection limit Chromatography Eosin 010405 organic chemistry Spectrum Analysis 010401 analytical chemistry Temperature Reproducibility of Results Buffer solution Hydrogen-Ion Concentration Azelastine Atomic and Molecular Physics and Optics 0104 chemical sciences Pharmaceutical Preparations chemistry Eosine Yellowish-(YS) Phthalazines medicine.drug |
| Zdroj: | Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 191:413-420 |
| ISSN: | 1386-1425 |
| DOI: | 10.1016/j.saa.2017.10.049 |
| Popis: | Two simple, sensitive, rapid, validated and cost effective spectroscopic methods were established for quantification of antihistaminic drug azelastine (AZL) in bulk powder as well as in pharmaceutical dosage forms. In the first method (A) the absorbance difference between acidic and basic solutions was measured at 228 nm, whereas in the second investigated method (B) the binary complex formed between AZL and Eosin Y in acetate buffer solution (pH 3) was measured at 550 nm. Different criteria that have critical influence on the intensity of absorption were deeply studied and optimized so as to achieve the highest absorption. The proposed methods obeyed Beer's low in the concentration range of (2.0–20.0 μg·mL− 1) and (0.5–15.0 μg·mL− 1) with % recovery ± S.D. of (99.84 ± 0.87), (100.02 ± 0.78) for methods (A) and (B), respectively. Furthermore, the proposed methods were easily applied for quality control of pharmaceutical preparations without any conflict with its co-formulated additives, and the analytical results were compatible with those obtained by the comparison one with no significant difference as insured by student's t-test and the variance ratio F-test. Validation of the proposed methods was performed according the ICH guidelines in terms of linearity, limit of quantification, limit of detection, accuracy, precision and specificity, where the analytical results were persuasive. |
| Databáze: | OpenAIRE |
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