scholarly journals Spectrophotometric and Chromatographic Methods for the Estimation of Raloxifene Hydrochloride in Bulk and Pharmaceutical Formulations

2013 ◽  
Vol 3 (4) ◽  
pp. 378-386 ◽  
Author(s):  
Bahia Moussa
2007 ◽  
Vol 4 (1) ◽  
pp. 79-82 ◽  
Author(s):  
M. Mathrusri Annapurna ◽  
M. E. Bhanoji Rao ◽  
B. V. V. Ravi Kumar

Three new simple, sensitive, rapid and economical spectrophotometric Methods (A, B and C) have been developed for the determination of Raloxifene Hydrochloride in pharmaceutical bulk and tablet dosage form. Method A is based on the formation of yellow colored chromogen with 0.1N Sodium hydroxide exhibiting maximum absorbance against the corresponding reagent blank. The method B is based on the reaction of Raloxifene with Ferric chloride and 1, 10-phenanthroline to form blood red colored chromogen. The method C is based on the formation of blood red colored chromogen with Ferric chloride and 2, 2' bipyridyl. The absorbencies of the chromogens were measured at their respective wavelength of maximum absorbance against the corresponding reagent blank. The proposed methods have been successfully applied to the analysis of the bulk drug and its tablet dosage form. The methods have been statistically evaluated and were found to be precise and accurate.


Author(s):  
Hany Ibrahim ◽  
Abdallah M Hamdy ◽  
Hanan A Merey ◽  
Ahmed S Saad

Abstract Background Paracetamol is one of the most widely analgesic and antipyretic drugs recently integrated into the supportive therapy of COVID-19. The pharmaceuticals containing methionine with paracetamol may contribute to avoid hepatotoxicity and eventual paracetamol overdose-dependent death. Objective The current work purposes to develop and validate two chromatographic methods for the simultaneous determination of methionine and paracetamol in presence of two paracetamol impurities (4-nitrophenol and 4-aminophenol). Methods Two chromatographic methods were established and validated according to the International Conference on Harmonization guidelines. The first one was a RP-HPLC/UV method based on applying a “dual-mode” gradient elution. The separation was realized via varying both the composition of the ternary mobile phase (acetonitrile–methanol–water) and its flow rate. This strategy enabled a relatively rapid analysis with a satisfactory resolution, although the investigated compounds exhibit a significant difference in lipophilicity. The second one relied on TLC- densitometry, where the optimum separation was realized using a quaternary mobile phase system composed of butanol–dioxane–toluene–methanol (8: 2.5: 3.5: 0.3, by volume). Both methods were monitored at 220 nm. Results The developed methods were proven to be robust, accurate, specific, and appropriate for the routine analysis of paracetamol in its pure form or in pharmaceutical formulations with methionine in quality control laboratories. Conclusions The corresponding methods are suitable to determine methionine and paracetamol in the presence of paracetamol impurities. Highlights The study achieves the analysis of methionine and paracetamol in the presence of paracetamol impurities via the application of HPLC and TLC- densitometry methods.


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