Stability Indicating Spectrophotometric and Chemometric Methods for Determination of Nifuroxazide in Presence of Its Alkaline Degradation Products

2011 ◽  
Vol 02 (05) ◽  
Author(s):  
Maha A. Hegazy ◽  
Waleed A. Hassanain ◽  
Laila E .Abdel-Fattah
Keyword(s):  
Degradation Products ◽  
Alkaline Degradation ◽  
Chemometric Methods ◽  
Stability Indicating

scholarly journals Stability-indicating HPLC and PLS chemometric methods for the determination of acemetacin in presence of its degradation products and impurities

2015 ◽  
Vol 6 (4) ◽  
pp. 422-429 ◽  
Author(s):  
Amira Mohamed Kessiba ◽  
Maha Abdel Monen Hegazy ◽  
Mohamed Mohamed Abdelkawy ◽  
Ahmed Emad El Gendy
Keyword(s):  
Degradation Products ◽  
Chemometric Methods ◽  
Stability Indicating

Stability Indicating Spectrophotometric and Chemometric Methods for Determination of Aripiprazole in Presence of its Degradation Products, A Comparative Study

2019 ◽  
Vol 9 (2) ◽  
pp. 258-272
Author(s):  
Christine M. El-Maraghy ◽  
Hesham Salem ◽  
Sawsan M. Amer ◽  
Marianne Nebsen
Keyword(s):  
Comparative Study ◽  
Degradation Products ◽  
Chemometric Methods ◽  
Stability Indicating

scholarly journals Development of Advanced Chemometric-Assisted Spectrophotometric Methods for the Determination of Cromolyn Sodium and Its Alkaline Degradation Products

Molecules ◽  
2020 ◽  
Vol 25 (24) ◽  
pp. 5953
Author(s):  
Noha M. El Zahar ◽  
Mariam M. Tadros ◽  
Bassam M. Ayoub
Keyword(s):  
Degradation Products ◽  
Principal Component Regression ◽  
Principal Component ◽  
Pharmaceutical Products ◽  
Partial Least Square ◽  
Cromolyn Sodium ◽  
Least Square ◽  
Alkaline Degradation ◽  
Stability Indicating

Advanced and sensitive spectrophotometric and chemometric analytical methods were successfully established for the stability-indicating assay of cromolyn sodium (CS) and its alkaline degradation products (Deg1 and Deg2). Spectrophotometric mean centering ratio spectra method (MCR) and chemometric methods, including principal component regression (PCR) and partial least square (PLS-2) methods, were applied. Peak amplitudes after MCR at 367.8 nm, 373.8 nm and 310.6 nm were used within linear concentration ranges of 2–40 µg mL−1, 5–40 µg mL−1 and 10–100 µg mL−1 for CS, Deg1 and Deg2, respectively. For PCR and PLS-2 models, a calibration set of eighteen mixtures and a validation set of seven mixtures were built for the simultaneous determination of CS, Deg1 and Deg2 in the ranges of 5–13 µg mL−1, 8–16 µg mL−1, and 10–30 µg mL−1, respectively. The authors emphasize the importance of a stability-indicating strategy for the investigation of pharmaceutical products.

Liquid chromatography and chemometric methods for determination of rofecoxib in presence of its photodegradate and alkaline degradation products

2004 ◽  
Vol 519 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Mostafa A Shehata ◽  
Ahmed Ashour ◽  
Nagiba Y Hassan ◽  
Ahmad S Fayed ◽  
Badr A El-Zeany
Keyword(s):  
Liquid Chromatography ◽  
Degradation Products ◽  
Alkaline Degradation ◽  
Chemometric Methods

Stability Indicating Spectrophotometric and Chemometric Methods for Determination of Buflomedil in Presence of its Acid Induced Degradation Products

2013 ◽  
Vol 3 (5-6) ◽  
pp. 342-358
Author(s):  
Azza Aziz Moustafa ◽  
Hesham Salem ◽  
Maha Hegazy ◽  
Omnia Ali
Keyword(s):  
Degradation Products ◽  
Chemometric Methods ◽  
Stability Indicating

Stability Indicating Liquid Chromatographic Method for the Determination of Fenofibrate and its Application to Kinetic Studies

2013 ◽  
Vol 5 (4) ◽  
pp. 1866-1874
Author(s):  
K. Srinivasa Rao ◽  
Keshar N K ◽  
N Jena ◽  
M.E.B Rao ◽  
A K Patnaik
Keyword(s):  
Degradation Products ◽  
Kinetic Studies ◽  
Pharmaceutical Formulations ◽  
Assay Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Zero Order Kinetics ◽  
Relative Standard ◽  
Liquid Chromatographic

A stability-indicating LC assay method was developed for the quantitative determination of fenofibrate (FFB) in pharmaceutical dosage form in the presence of its degradation products and kinetic determinations were evaluated in acidic, alkaline and peroxide degradation conditions. Chromatographic separation was achieved by use of Zorbax C18 column (250 × 4.0 mm, 5 μm). The mobile phase was established by mixing phosphate buffer (pH adjusted 3 with phosphoric acid) and acetonitrile (30:70 v/v). FFB degraded in acidic, alkaline and hydrogen peroxide conditions, while it was more stable in thermal and photolytic conditions. The described method was linear over a range of 1.0-500 μg/ml for determination of FFB (r= 0.9999). The precision was demonstrated by relative standard deviation (RSD) of intra-day (RSD= 0.56– 0.91) and inter-day studies (RSD= 1.47). The mean recovery was found to be 100.01%. The acid and alkaline degradations of FFB in 1M HCl and 1M NaOH solutions showed an apparent zero-order kinetics with rate constants 0.0736 and 0.0698  min−1 respectively and the peroxide degradation with 5% H2O2 demonstrated an apparent first-order kinetics with rate constant k = 0.0202 per min. The t1/2, t90   values are also determined for all the kinetic studies. The developed method was found to be simple, specific, robust, linear, precise, and accurate for the determination of FFB in pharmaceutical formulations.  

ICH/FDA Guidelines-Compliant Validated Stability-Indicating HPLC-UV Method for the Determination of Axitinib in Bulk and Dosage Forms

2020 ◽  
Vol 16 (8) ◽  
pp. 1106-1112
Author(s):  
Ibrahim A. Darwish ◽  
Nasr Y. Khalil ◽  
Mohammad AlZeer
Keyword(s):  
High Performance ◽  
Kinase Inhibitor ◽  
Degradation Products ◽  
Internal Standard ◽  
Dosage Forms ◽  
Uv Detector ◽  
Stability Indicating ◽  
Therapeutic Benefits ◽  
Relative Standard

Background: Axitinib (AXT) is a member of the new generation of the kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. Its therapeutic benefits depend on assuring the good-quality of its dosage forms in terms of content and stability of the pharmaceutically active ingredient. Objective: This study was devoted to the development of a simple, sensitive and accurate stabilityindicating high-performance liquid chromatographic method with ultraviolet detection (HPLC-UV) for the determination of AXT in its bulk and dosage forms. Methods: Waters HPLC system was used. The chromatographic separation of AXT, internal standard (olaparib), and degradation products were performed on the Nucleosil CN column (250 × 4.6 mm, 5 μm). The mobile phase consisted of water:acetonitrile:methanol (40:40:20, v/v/v) with a flow rate of 1 ml/min, and the UV detector was set at 225 nm. AXT was subjected to different accelerated stress conditions and the degradation products, when any, were completely resolved from the intact AXT. Results: The method was linear (r = 0.9998) in the concentration range of 5-50 μg/ml. The limits of detection and quantitation were 0.85 and 2.57 μg/ml, respectively. The accuracy of the method, measured as recovery, was in the range of 98.0-103.6% with relative standard deviations in the range of 0.06-3.43%. The results of stability testing revealed that AXT was mostly stable in neutral and oxidative conditions; however, it was unstable in alkaline and acidic conditions. The kinetics of degradation were studied, and the kinetic rate constants were determined. The proposed method was successfully applied for the determination of AXT in bulk drug and dosage forms. Conclusions: A stability-indicating HPLC-UV method was developed and validated for assessing AXT stability in its bulk and dosage forms. The method met the regulatory requirements of the International Conference on Harmonization (ICH) and the Food and Drug Administration (FDA). The results demonstrated that the method would have great value when applied in quality control and stability studies for AXT.

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