Stability-indicating spectrophotometric and spectrodensitometric methods for the determination of diacerein in the presence of its degradation product

2010 ◽  
Vol 3 (4) ◽  
pp. 221-227 ◽  
Author(s):  
Marianne Nebsen ◽  
Mohamed K. Abd El-Rahman ◽  
Maissa Y. Salem ◽  
Amira M. El-Kosasy ◽  
Mohamed G. El-Bardicy
Keyword(s):  
Degradation Product ◽  
Stability Indicating

scholarly journals Stability-Indicating Methods for Determination of Pyritinol Dihydrochloride in the Presence of Its Precursor and Degradation Product by Derivative Spectrophotometry

2005 ◽  
Vol 88 (1) ◽  
pp. 80-86 ◽  
Author(s):  
Mostafa A Shehata ◽  
Mohammad A El-Sayed ◽  
Mohammad G El-Bardicy ◽  
Mohammad F El-Tarras
Keyword(s):  
Hydrochloric Acid ◽  
Degradation Product ◽  
Pharmaceutical Formulations ◽  
Zero Crossing ◽  
Stability Indicating ◽  
First Derivative ◽  
Linear Relationships ◽  
Assay Methods ◽  
Powdered Form

Abstract A first-derivative spectrophotometric (1D) method and a derivative-ratio zero-crossing spectrophotometric (1DD) method were used to determine pyritinol dihydrochloride (I) in the presence of its precursor (II) and its degradation product (III) with 0.1N hydrochloric acid as a solvet. Linear relationships were obtained in the ranges of 6–22 μg/mL for the (1D) method and 6–20 μg/mL for the (1DD) method. By applying the proposed methods, it was possible to determine pyritinol dihydrochloride in its pure powdered form with an accuracy of 100.36 ± 1.497% (n = 9) for the (1D) method and an accuracy of 99.92 ± 1.172% (n = 8) for the (1DD) method. Laboratory-prepared mixtures containing different ratios of (I), (II), and (III) were analyzed, and the proposed methods were valid for concentrations of ≤10% (II) and ≤50% (III). The proposed methods were validated and found to be suitable as stability-indicating assay methods for pyritinol in pharmaceutical formulations.

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.

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