استخدام طريقة طيفية جديدة ذات مصداقية لتحديد سفترياكسون الصوديوم بتشكيل معقد مع شوارد النحاس الثنائية
Abstract
A simple, accurate and sensitive UV-Visible spectrophotometric method have been used and validated for the quantitative determination of ceftriaxone sodium in either pure form or in its pharmaceutical vials. The method is based on the formation of a complex with copper(II). Appropriate conditions were examined for the reaction to obtain maximum absorptivity and sensitivity. Under the optimum reaction conditions, linear relationship with good correlation coefficient (0.999) was found between the concentrations and the absorbance of the formed complex. The color of the produced complex is measured at 635nm. The molar absorptivity is 1.16× 10 4L mol-1cm-1and Sandell's sensitivity is 0.057µg/cm2. The method is applicable over concentration range of 8 – 70 µg/ml. The results of analysis have been validated statistically, and recovery studies confirmed the accuracy of the proposed method which was carried out by following the ICH guidelines. Furthermore, the developed method hold its accuracy and precision well when applied to the determination of ceftriaxone sodium in its pharmaceutical vials. تم في هذا البحث استخدام طريقة بسيطة، حساسة، ودقيقة لمعايرة سيفترياكسون الصوديوم بشكل النقي وفي الأشكال التجارية الحاوية عليه من خلال تشكيل معقد مع شوارد النحاس الثنائي باستخدام مقياس الطيف الضوئي في المجال المرئي. تم فحص الظروف المناسبة للتفاعل للحصول على الحد الأقصى من الامتصاصية وحساسية الطريقة وبعد تحديد الشروط المناسبة للتفاعل وجد هنالك علاقة طردية بين تركيز الدواء والامتصاصية مع معامل ارتباط 999,0. أعطى المعقد الناتج امتصاصية عظمى عند طول موجة 635 نانومتر مع معامل امتصاص مولي410 × 1.16 ل مول-1 سم-1وحساسية ساندال 0.057 مكغ / مل. تم التحقق من مصدوقية الطريقة التحليلية المتبعة فكانت خطية ضمن المجال 8 – 70 مكغ / مل مع حد كشف كيفي 0.84 مكغ / مل وحد كمي 2.55 مكغ / مل. تتمتع الطريق المتبعة بدقة ومضبوطية ونوعية عالية مع نسبة استرداد قريبة من 100% وذلك وفق مبادئ ICH كما حافظت الطريقة التحليلية على دقتها أثناء فحص الأشكال الحقنية المدروسة.Downloads
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