Stability-indicating spectrophotometric methods for determination of tazarotene in the presence of its alkaline degradation product by derivative spectrophotometric techniques

2010 ◽  
pp. n/a-n/a ◽  
Author(s):  
Amr M. Badawy ◽  
Abd El-Aziz B. Abd El-Alim ◽  
Ahmed S. Saad
Keyword(s):  
Degradation Product ◽  
Alkaline Degradation ◽  
Stability Indicating ◽  
Spectrophotometric Methods

scholarly journals Development and validation of stability-indicating RP-HPLC method for determination of Olmesartan medoxomile in pharmaceutical dosage form and identification, characterization of alkaline degradation impurity of Olmesartan medoxomile drug substance as well as drug product

2012 ◽  
Vol 18 (4-1) ◽  
pp. 595-604 ◽  
Author(s):  
P.S. Jain ◽  
A.J. Chaudhari ◽  
S.J. Surana
Keyword(s):  
Degradation Product ◽  
Drug Product ◽  
Olmesartan Medoxomil ◽  
Hplc Method ◽  
Drug Substance ◽  
Alkaline Degradation ◽  
Stability Indicating ◽  
Rp Hplc

Olmesartan Medoxomil (OLME) belongs to a group of angiotensin II receptor blockers used as an antihypertensive agent and is currently being used for prevention of Hypertension. This paper describes the Validation and development of stability indicating RP-HPLC method for the determination of OLME in the presence of its degradation products generated from forced degradation study and characterization of degradation product (impurity). The assay involved gradient elution of OLME on An LC GC BDS C18 column (250 ? 4.5mm, 5-?m particle size) was employed for loading the sample. The mobile phase A consists of 7 ml Triethylamine in 1000 ml water (pH adjusted to 3.0 with orthophosphoric acid) and B contains acetonitrile. Quantification was achieved with photodiode array detection at 257 nm. The chromatographic separation was obtained with a retention time of 6.72 min, and the method was linear in the range 50-150 ?g/ml. The method was validated according to the ICH guidelines with respect to linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), specificity and robustness. Impurity found in stressed and stability studies of Olmesartan Medoxomil in both drug substance and drug product are described. This degradation product is identified as 1-(biphenyl-4-ylmethyl)-1H-imidazole-5-carboxylic acid. An Alkaline degradation pathway of Olmesartan medoxomil, for the formation of this degradation product, has been proposed and degradation product was characterized.

scholarly journals Stability-indicating methods for the determination of pipazethate HCl in the presence of its alkaline degradation product

2010 ◽  
Vol 1 (1) ◽  
pp. 71-78 ◽  
Author(s):  
Yasser S. El-Saharty ◽  
Nariman A. El-Ragehy ◽  
Heba M. Abdel-Monem ◽  
Mohammed I. Abdel-Kawy
Keyword(s):  
Degradation Product ◽  
Alkaline Degradation ◽  
Stability Indicating

Stability indicating spectrophotometric methods for quantitative determination of bromazepam and its degradation product

2020 ◽  
Vol 238 ◽  
pp. 118433
Author(s):  
Hany W. Darwish ◽  
Nesma A. Ali ◽  
Ibrahim A. Naguib ◽  
Mohamed R. El Ghobashy ◽  
Abdullah M. Al-Hossaini ◽  
...  
Keyword(s):  
Quantitative Determination ◽  
Degradation Product ◽  
Stability Indicating ◽  
Spectrophotometric Methods

scholarly journals Smart Stability-Indicating Spectrophotometric Methods for Determination of Binary Mixtures Without Prior Separation

2008 ◽  
Vol 91 (2) ◽  
pp. 299-310 ◽  
Author(s):  
Mohammad G El-Bardicy ◽  
Hayam M Lotfy ◽  
Mohammad A El-Sayed ◽  
Mohammad F El-Tarras
Keyword(s):  
Degradation Product ◽  
Total Content ◽  
Standard Addition ◽  
Pharmaceutical Formulations ◽  
Assay Method ◽  
Isosbestic Point ◽  
Subtraction Method ◽  
Stability Indicating ◽  
Spectrophotometric Methods

Abstract Ratio subtraction and isosbestic point methods are 2 innovating spectrophotometric methods used to determine vincamine in the presence of its acid degradation product and a mixture of cinnarizine (CN) and nicergoline (NIC). Linear correlations were obtained in the concentration range from 840 g/mL for vincamine (I), 622 g/mL for CN (II), and 636 g/mL for NIC (III), with mean accuracies 99.72 0.917 for I, 99.91 0.703 for II, and 99.58 0.847 and 99.83 1.039 for III. The ratio subtraction method was utilized for the analysis of laboratory-prepared mixtures containing different ratios of vincamine and its degradation product, and it was valid in the presence of up to 80 degradation product. CN and NIC in synthetic mixtures were analyzed by the 2 proposed methods with the total content of the mixture determined at their respective isosbestic points of 270.2 and 235.8 nm, and the content of CN was determined by the ratio subtraction method. The proposed method was validated and found to be suitable as a stability-indicating assay method for vincamine in pharmaceutical formulations. The standard addition technique was applied to validate the results and to ensure the specificity of the proposed methods.

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