scholarly journals Development and validation of RP-HPLC method for stability evaluation of model hydrazone, containing a pyrrole ring

Pharmacia ◽  
2019 ◽  
Vol 66 (3) ◽  
pp. 127-134
Author(s):  
Diana Tzankova ◽  
Lily Peikova ◽  
Stanislava Vladimirova ◽  
Maya Georgieva

RP-HPLC method with UV detection was developed and validated for determination of the chemical stability and stability in close to physiological conditions of a model pyrrole hydrazone ethyl 5-(4-bromophenyl)-1-(1-(2-(4-hydroxy-3-methoxybenzylidene) hydrazineyl)-4-methyl-1-oxopentan-2-yl)-2-methyl-1H-pyrrole-3-carboxylate (D_5d), containing susceptible to hydrolysis hydrazone group. The evaluated substance was subjected to the influence of a variety of pH , representing the main physiological values of 37°C and corresponding pH values in the stomach (pH 2.0), blood (pH 7.4) and small intestine (pH 9.0). Chemical stability in a highly alkaline medium with a pH of 13.0 was also evaluated. The hydrazone I tested was found to be stable at pH 7.4 and pH 9.0 and 37 ° C and hydrolyzed under strong acidic (pH 2.0) and highly alkaline media (pH 13.0) and at the same temperature.The products of hydrolysis were identified to be the initial hydrazide and aldehyde, pointing the hydrazone group as most liable.

2018 ◽  
Vol 6 ◽  
pp. 1192-1198 ◽  
Author(s):  
Diana Tzankova ◽  
Lily Peikova ◽  
Maya Georgieva

A validated UV/VIS method for preliminary determination of the chemical stability and stability in close to physiological conditions of a model pyrrole hydrazide and its corresponding derivative, bearing susceptible to hydrolysis hydrazone group was developed. The evaluated substances were subjected to the influence of a variety of pH medias, representing the main physiological values of 37°C and corresponding pH values in the stomach (pH 2.0), blood (pH 7.4) and small intestine (pH 9.0). The chemical stability at strong alkali media of pH 13.0 was also evaluated. The hydrazide was found to be stable at all investigated conditions. The tested hydrazone was determined to be stable at pH of 7.4 and a temperature of 37°C and susceptible to hydrolysis at strong acidic (pH 2.0) and moderate alkali (pH 9.0) media at the same temperature. In addition, a decrease in the absorption at strong alkali media (pH 13.0) was observed, showing the compounds instability under these conditions.


2010 ◽  
Vol 7 (3) ◽  
pp. 807-812 ◽  
Author(s):  
Vanita Somasekhar ◽  
D. Gowri Sankar

A reverse phase HPLC method is described for the determination of esmolol hydrochloride in bulk and injections. Chromatography was carried on a C18column using a mixture of acetonitrile, 0.05 M sodium acetate buffer and glacial acetic acid (35:65:3 v/v/v) as the mobile phase at a flow rate of 1 mL/min with detection at 275 nm. The retention time of the drug was 4.76 min. The detector response was linear in the concentration of 1-50 μg/mL. The limit of detection and limit of quantification was 0.614 and 1.86 μg/mL respectively. The method was validated by determining its sensitivity, linearity, accuracy and precision. The proposed method is simple, economical, fast, accurate and precise and hence can be applied for routine quality control of esmolol hydrochloride in bulk and injections.


2021 ◽  
Vol 11 (5) ◽  
pp. 708-718
Author(s):  
Ravindra Mallavarapu ◽  
Kommera Pavithra ◽  
Naresh Kumar Katari ◽  
Thirupathi Dongala

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