Analysis of flunarizine in the presence of some of its degradation products using micellar liquid chromatography (MLC) or microemulsion liquid chromatography (MELC) - Application to dosage forms

2005 ◽  
Vol 28 (2) ◽  
pp. 197-202 ◽  
Author(s):  
Dina T. El-Sherbiny ◽  
Manal I. Eid ◽  
Dalia R. El-Wasseef ◽  
Riyad M. Al-Ashan ◽  
Fathalla Belal
Keyword(s):  
Liquid Chromatography ◽  
Degradation Products ◽  
Dosage Forms ◽  
Micellar Liquid Chromatography ◽  
Microemulsion Liquid Chromatography

scholarly journals Validated Stability – Indicating Methods for Determination of Sofosbuvir by UPLC and HPTLC in Pure Form and Tablet Dosage Forms

2019 ◽  
pp. 1-13
Author(s):  
Sawsan A. Abdel-Razeq ◽  
Zeinab Adel Nasr ◽  
Noha S. Said
Keyword(s):  
Liquid Chromatography ◽  
Thin Layer ◽  
High Performance ◽  
Good Accuracy ◽  
Degradation Products ◽  
Dosage Forms ◽  
Stability Indicating ◽  
Accuracy And Precision ◽  
Tablet Dosage

Aims: Two simple and sensitive stability- indicating methods were developed and validated for the quantitative determination of sofosbuvir in presence of its degradation products. Study Design: Ultra high performance liquid chromatography (UPLC), High performance thin layer chromatography (HPTLC) are developed for determination of sofosbuvir in presence of its degradation products, laboratory-prepared mixtures and in tablet dosage forms. Place and Duration of Study: Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al-Azhar University, between August 2018 and March 2019. Methodology: Two simple and sensitive stability- indicating methods were developed and validated for the quantitative determination of Sofosbuvir in presence of its degradation products. The first method was an Ultra Performance Liquid Chromatography (UPLC) method, in which efficient separation was carried out on phenomenex kinetex 2.6 μm C18 100 A column using a mobile phase consisting of filtered and degassed mixture of 0.1% ortho-phosphoric acid in water and methanol with the ratio of (40:60% v/v) adjusted to pH 3.5, at a flow rate of 1 mL min-1 and UV detection at 260 nm at ambient temperature. The second method is a high performance- thin layer chromatographic one (HPTLC) in which chromatographic separation was performed on silica gel 60 F254 plates, with methanol – chloroform – ammonia (2.5: 6: 1.5 % v/v/v) as a developing system followed by densitometric determination at 261 nm. Sofosbuvir was subjected to stress conditions including alkaline, acidic and oxidative degradation. Results: Beer’s law was obeyed over the range of 1-20 μg mL–1 for UPLC and 2-12 μg / spot for HPTC with good accuracy and precision using the two procedures, respectively. Results obtained was statistically analysed and found to be in accordance with those given by the reported method. Conclusion: The proposed methods were successfully applied for the determination of sofosbuvir in bulk powder, laboratory prepared mixtures and pharmaceutical dosage form with good accuracy and precision. The methods were validated according to ICH guidelines. The results obtained were compared with those of the reported method and were found to be in good agreement.

Determination of Menbutone in Bovine Milk and Meat Using Micellar Liquid Chromatography: Application to Injectable Dosage Forms

2015 ◽  
Vol 9 (3) ◽  
pp. 638-645 ◽  
Author(s):  
F. Belal ◽  
Sawsan A. Abd El-Razeq ◽  
Manal M. Fouad ◽  
S. Zayed ◽  
Fatma A. Fouad
Keyword(s):  
Liquid Chromatography ◽  
Bovine Milk ◽  
Dosage Forms ◽  
Micellar Liquid Chromatography ◽  
Injectable Dosage

Micellar liquid chromatography of plant extracts components

2014 ◽  
Vol 27 (6) ◽  
pp. 420-427 ◽  
Author(s):  
Katarzyna Stępnik ◽  
Irena Malinowska ◽  
Edward Rój
Keyword(s):  
Liquid Chromatography ◽  
Plant Extracts ◽  
Micellar Liquid Chromatography

The Influence of Some Factors on Spirolactone Stability in Solution

2008 ◽  
Vol 59 (7) ◽  
Author(s):  
Daniela Lucia Muntean ◽  
Silvia Imre ◽  
Cosmina Voda
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Uv Irradiation ◽  
High Performance ◽  
Degradation Products ◽  
Simultaneous Action ◽  
Ethanolic Solution ◽  
Degradation Processes ◽  
Stable Solutions ◽  
Preformulation Study

The influence of some factors on spironolactone stability in solution was studied, by applying high-performance liquid chromatography, as a part of a pharmaceutical preformulation study in order to obtain a spironolactone solution for alopecia treatment. Solutions of 1 mg/ml spironolactone in aqueous ethanolic solution 1 : 1 and in 20 mM cyclodextrines solutions (b-, hydroxi-b- and methyl-b-cyclodextrine) was used, maintained at 8 and 22 �C, protected from light and after UV irradiation at 254 nm. The main degradation products were 7a-thiospirolactone and canrenone. The most stable solutions were the alcoholic ones and with methyl-beta-cyclodextrine, but the simultaneous action of temperature and UV irradiation allowed degradation processes after one hour of exposure, more aggressive in the presence of methyl-beta-cyclodextrine. In conclusion, for alopecia treatment with spironolactone a 1 mg/mL ethanolic solution could be used and it is recommendable the protection of treated zone.

A Comprehensive Review on Importance and Quantitation of Atypical Antipsychotic Drugs and their Active Metabolites in Commercial Dosage Forms

2020 ◽  
Vol 16 (8) ◽  
pp. 989-1019
Author(s):  
Habibur Rahman ◽  
S.K. Manirul Haque ◽  
Masoom Raza Siddiqui
Keyword(s):  
Mass Spectrometry ◽  
Gas Chromatography ◽  
Liquid Chromatography ◽  
Antipsychotic Drugs ◽  
Method Development ◽  
Early Death ◽  
Dosage Forms ◽  
Gas Chromatography Mass Spectrometry ◽  
Active Metabolites ◽  
Chromatography Mass Spectrometry

Background: Schizophrenia is a severe mental illness that affects more than twenty-one million people throughout the world. Schizophrenia also causes early death. Schizophrenia and other related psychotic ailments are controlled by the prescription of antipsychotic drugs, which act by blocking certain chemical receptors in the brain and thus relieves the symptoms of psychotic disorder. These drugs are present in the different dosage forms in the market and provided in a certain amount as per the need of the patients. Objective: Since such medications treat mental disorders, it is very important to have a perfect and accurate dose so that the risk factor is not affected by a higher or lower dose, which is not sufficient for the treatment. For accurate assay of these kinds of drugs, different analytical methods were developed ranging from older spectrophotometric techniques to latest hyphenated methods. Results: The current review highlights the role of different analytical techniques that were employed in the determination and identification of antipsychotic drugs and their metabolites. Techniques such as spectrophotometry, fluorimetry, liquid chromatography, liquid chromatography-mass spectrometry, gas chromatography, and gas chromatography-mass spectrometry employed in the method development of such antipsychotic drugs were reported in the review. Different metabolites, identified using the hyphenated techniques, were also mentioned in the review. The synthesis pathways of few of the metabolites were mentioned. Conclusion: The review summarizes the analyses of different antipsychotic drugs and their metabolites. A brief introduction of illnesses and their symptoms and possible medications were highlighted. Synthesis pathways of the associated metabolites were also mentioned.

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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