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Development of Spectrophotometric and HPLC Methods for the determination of Azelastine as Raw material and in Dosage form

تطوير طريقة ضوئية و أخرى بالاستشراب السائل عالي الأداء لمعايرة الأزيلاستين بوصفه مادةً أوليةً و في أشكاله الصيدلانية

1803   0   11   0 ( 0 )
 Publication date 2013
  fields Pharmacy
and research's language is العربية
 Created by Shamra Editor




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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.


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Research summary
في هذا البحث، تم تطوير طريقتين تحليليتين لتحديد مادة الأزيلاستين بوصفها مادة أولية وفي أشكالها الصيدلانية كبخاخ أنفي. الطريقة الأولى تعتمد على تقنية الطيف الضوئي، حيث تم قياس الامتصاص عند طول موجة الامتصاص الأعظمي 284 نانومتر. أظهرت النتائج علاقة طردية بين الامتصاص والتركيز ضمن المجال 0.001 - 0.008 غ%. تم تطبيق هذه الطريقة بنجاح على بخاخ الأنف، وكانت نسبة المردود 99.378 ± 1.1%. لم تؤثر السواغات الداخلية في المستحضرات على امتصاص المادة عند طول موجتها الأعظمية. الطريقة الثانية تعتمد على تقنية الاستشراب السائل عالي الأداء (HPLC) باستخدام عمود فصل ODS (C18) بطول 25 سم وقطر 4.6 ملم، وطور متحرك من الأسيتونتريل مع وقاء فوسفاتي بنسبة 1:1. أظهرت المادة فصلاً جيداً وزمن احتباس 1.467 دقيقة. تم التحقق من دقة ومصداقية الطريقتين مقارنة بالطريقة الدستورية.
Critical review
دراسة نقدية: يعتبر البحث ذو أهمية كبيرة في مجال التحليل الصيدلاني، حيث يقدم طرقاً دقيقة وموثوقة لمعايرة الأزيلاستين في أشكاله الصيدلانية. ومع ذلك، يمكن أن تكون هناك بعض النقاط التي تحتاج إلى تحسين. على سبيل المثال، قد يكون من المفيد توسيع نطاق الدراسة لتشمل أشكال صيدلانية أخرى غير البخاخ الأنفي. بالإضافة إلى ذلك، يمكن أن تكون هناك حاجة لمزيد من الدراسات للتحقق من تأثير العوامل البيئية المختلفة على دقة وموثوقية الطريقتين. كما يمكن أن يكون من المفيد تقديم مقارنة أكثر تفصيلاً بين الطريقتين المطورتين والطريقة الدستورية من حيث التكلفة والوقت والكفاءة.
Questions related to the research
  1. ما هي الطريقتان التحليليتان المستخدمتان في البحث؟

    الطريقتان هما تقنية الطيف الضوئي وتقنية الاستشراب السائل عالي الأداء (HPLC).

  2. ما هو طول موجة الامتصاص الأعظمي المستخدم في تقنية الطيف الضوئي؟

    طول موجة الامتصاص الأعظمي المستخدم هو 284 نانومتر.

  3. ما هي نسبة المردود للطريقة الطيفية عند تطبيقها على بخاخ الأنف؟

    نسبة المردود كانت 99.378 ± 1.1%.

  4. ما هو زمن الاحتباس الذي تم الحصول عليه باستخدام تقنية HPLC؟

    زمن الاحتباس كان 1.467 دقيقة.


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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