طُورت في هذا البحث طريقتا تحليل لمادة الأزيلاستين بوصفه مادةً أوليةً و في شكلها الصيدلاني بخاخ أنفي الأولى باستخدام تقنية الطيف الضوئي و الثانية باستخدام تقنية ال HPLC.
تعتمد الطريقة الأولى على قياس الامتصاص عند طول موجة الامتصاص الأعظمي 284 نم إِذ قيس الأمتصاص عند طول الموجة المذكورة، و كانت العلاقة طردية بين الامتصاص و التركيز ضمن المجال 0.001 - 0.008 غ%.
و قد طبقَتِ الطريقة على معايرة المادة في مستحضرها الصيدلاني /بخاخ أنفي/ و كانت النسبة المئوية للمردود ( 10 قراءات مكررة) هي 1.1 ± 99.378.
و قد وجد أن السواغات الداخلية في المستحضرات لا تؤثر في امتصاص المادة عند طول موجتها الأعظمية، كما قورنت الطريقة بالطريقة الدستورية لمعايرة المادة الأولية.
المادة أعطت فصلاً جيداً، و كان زمن الاحتباس 1.467 دقيقة.
In this research two analytical methods were developed for the determination of Azelastin as raw material and in Nasal Spray formulation.
The first method was spectrophotometric while the other used the technic of HPLC The first method based on measuring the absorbance at λmax 284 nm .
The relationship between the absorbance and the concentration is rectilinear over the range 0.001 – 0.008 g %.
The proposed spectrophotometric method was successfully applied to the determination of Azelastin in nasal spray.
The percentage recoveries were 99.378±1 (10 duplicate readings)1
No interference was noticed from co-formulated drugs.
For the absorbance at λmax the obtained results were in good agreement with which obtained by the Pharmacopeia method.
The substance gave a good separation while the retention time was 1.467 min.
References used
(Japanese Pharmacopeia ( JP ,14th edition
European Pharmacopeia 7th edition 2011
United State Pharmacopeia ( USP 34-NF 29 )2013
British Pharmacopeia 2007
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