scholarly journals Determination of Albendazole in the Presence of its Alkaline Degradation Product Using TLC-Densitometric and Chemometric Methods: A Comparative Study

2017 ◽  
Vol 12 (4) ◽  
pp. 365-383 ◽  
Author(s):  
Khalid Attia ◽  
Ahmad Mohamad ◽  
Mohamed Emara
Keyword(s):  
Comparative Study ◽  
Degradation Product ◽  
Alkaline Degradation ◽  
Chemometric Methods

Determination of Rufinamide in the Presence of 1-[(2,6-Difluorophenyl)Methyl]-1H-1,2,3-Triazole-4 Carboxylic Acid Using RP-HPLC and Derivative Ratio Methods as Stability Indicating Assays to Be Applied on Dosage Form

2020 ◽  
Vol 103 (5) ◽  
pp. 1215-1222
Author(s):  
Sonia T Hassib ◽  
Hanaa M A Hashem ◽  
Marianne A Mahrouse ◽  
Eman A Mostafa
Keyword(s):  
Carboxylic Acid ◽  
Degradation Product ◽  
Dosage Form ◽  
Complementary Therapy ◽  
Therapeutic Drug ◽  
Forced Degradation ◽  
Alkaline Degradation ◽  
The European Union ◽  
Significant Difference

Abstract Background Rufinamide is a triazole derivative that is structurally dissimilar to other marketed antiepileptic drugs, has been assumed a marketing authorization, by the European Union and FDA, for use as a complementary therapy for seizures associated with Lennox-Gastaut syndrome. Objective This work is concerned with development of two methods for determination of rufinamide (RUF) in presence of 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxylic acid as its alkaline degradation product in dosage form. Methods The first method was capable of determing RUF in the presence of its alkaline degradation product and in dosage form. Kromasil C8 column and mobile phase consisting of acetonitrile–water (50:50, v/v) were used and UV detection at 210 nm. In the second method, first derivative ratio spectrophotometry, RUF was determined by measuring peak amplitude at 269.5 nm over 5–30 μg/mL. Results The linearity range of RUF was 10–90 μg/mL for HPLC method covering its therapeutic range with r2 = 0.9999. Forced degradation under alkaline conditions was carried out, the degradation product was isolated and its structure was confirmed. Both methods were validated in accordance to ICH guidelines. Statistical analysis revealed no significant difference between obtained results and reported ones. Conclusion The present study is useful for therapeutic drug monitoring and routine analysis of RUF in quality control laboratories. Highlights Kinetics of the alkaline degradation of RUF was studied by following the concentration of the remaining drug until complete degradation was achieved.

Determination of Cefoxitin Sodium in Presence of its Alkaline Degradation Product Using Two Wavelengths Manipulating Methods

2016 ◽  
Vol 6 (6) ◽  
pp. 738-747 ◽  
Author(s):  
Khalid A.M. Attia ◽  
Omar A.A. Ghonim ◽  
Nancy Magdy ◽  
Ghada F. Mohamed
Keyword(s):  
Degradation Product ◽  
Alkaline Degradation

scholarly journals Different Spectrophotometric Methods for Simultaneous Determination of Trelagliptin and Its Acid Degradation Product

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Shereen Mowaka ◽  
Bassam M. Ayoub ◽  
Mostafa A. Hassan ◽  
Wafaa A. Zaghary
Keyword(s):  
Degradation Product ◽  
Simultaneous Equation ◽  
Chemometric Methods ◽  
Acid Degradation ◽  
Spectrophotometric Methods ◽  
First Derivative ◽  
Mean Centering ◽  
Validation Parameters ◽  
Major Acid

New spectrophotometric and chemometric methods were carried out for the simultaneous assay of trelagliptin (TRG) and its acid degradation product (TAD) and applied successfully as a stability indicating assay to recently approved Zafatek® tablets. TAD was monitored using TLC to ensure complete degradation. Furthermore, HPLC was used to confirm dealing with one major acid degradation product. The proposed methods were developed by manipulating zero-order, first-derivative, and ratio spectra of TRG and TAD using simultaneous equation, first-derivative, and mean-centering methods, respectively. Using Spectra Manager II and Minitab v.14 software, the absorbance at 274 nm–260.4 nm, amplitudes at 260.4 nm–274.0 nm, and mean-centered values at 287.6 nm–257.2 nm were measured against methanol as a blank for TRG and TAD, respectively. Linearity and the other validation parameters were acceptable at concentration ranges of 5–50 μg/mL and 2.5–25 μg/mL for TRG and TAD, respectively. Using one-way analysis of variance (ANOVA), the optimized methods were compared and proved to be accurate for the simultaneous assay of TRG and TAD.

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