Validation of Simultaneous Volumetric and HPLC Methods for the Determination of Pridinol Mesylate in Raw Material

Simionato, Laura D.; Ferello, Leonardo; Stamer, Sebastian; Zubata, Patricia; Segall, Adriana Inés

doi:10.1155/2013/540676

ISRN Pharmaceutics

2013

DOI: 10.1155/2013/540676

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Validation of Simultaneous Volumetric and HPLC Methods for the Determination of Pridinol Mesylate in Raw Material

Laura D. Simionato

Leonardo Ferello

Sebastian Stamer

et al.

Abstract: Simple, sensitive, and economical simultaneous volumetric and HPLC methods for the determination of pridinol mesylate in raw material have been developed. The volumetric method is based on the reaction of pridinol with sodium lauryl sulphate in diluted sulphuric acid. Dimethyl yellow was used as indicator to detect the end point of the titration in aqueous/organic layer. The HPLC method for the determination of pridinol mesylate employs a reverse phase C18 column at ambient temperature with a mobile phase cons… Show more

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oncepts in development of fast, simple, stability indicating HPLC method for analysis of atorvastatin related compounds in tablets

Piponski¹,

Stoimenova²,

Piponska³

et al. 2018

JAPLR

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New, fast, simple and mild conditioned High Performance Liquid Chromatography (HPLC) method for determination of atorvastatin and its 7 main specified impurities, as well as unspecified impurities that might possibly appear, was developed. Chromatographic runs last between 25 and 40 minutes, with simple stepwise gradient elution. The main accent in our method development strategy was focused on mobile phase, composed of simple binary system composed of phosphate buffer and acetonitrile, at pH 4.1, without use of tetrahydrofuran, ion-pair reagents, trifluoroacetic acid and other modifiers with high Ultraviolet (UV) cut-off like absorptive acetate or formiate buffers or amines. With our concept of mobile phase, different columns from myriad were tested, with different efficiency, dimensions and properties, which resulted in different separation efficiency and run time. The best results, concerning essential critical peak resolution, run time length including column preparation and equilibration and column backpressure, were achieved with: YMC C18 Triart 150mm x 4.6mm, 3µm (YMC America, Inc.), afterwards with Nucleodur 100-3-C18ec 250mm x 4.6mm, 3µm (Macherey-Nagel GmbH & Co., Germany), Waters Symmetry C18 250mm x 4.6mm, 5µm (Waters, USA) and Superspher C18e 125mm x 4mm, 4µm (Merck, Darmstadt, Germany). All this columns achieve excellent results regarding obligated critical resolution between atorvastatin impurity B and atorvastatin (according to European Pharmacopoeia),1 or in some cases between atorvastatin impurity B and atorvastatin impurity C, to be minimum about 1.5, in both cases.

show abstract

oncepts in development of fast, simple, stability indicating HPLC method for analysis of atorvastatin related compounds in tablets

Piponski¹,

Stoimenova²,

Piponska³

et al. 2018

JAPLR

View full text Add to dashboard Cite

show abstract

Development of the Spectrophotometric Method for the Determination of Atorvastatin Calcium in Tablets by using Bromophenol Blue

Shulyak¹,

Protsyk²,

Kuche³

et al. 2022

MOCA

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A simple, rapid, and inexpensive spectrophotometric method for the determination of atorvastatin calcium in tablets has been developed. It requires only one reagent (BPB) and suitable for routine pharmaceutical analysis with less sophisticated equipment. The procedure for atorvastatin determination is based on its interaction with bromophenol blue (BPB) in medium of organic solvent. As a result of the reaction, the intensity of the band of the doubly ionized form of the BPB with a maximum at 595 nm increases. The maximum analytical signal is observed in a solution of methanol, chloroform, or acetonitrile, while ethanol and ethyl acetate turned out to be unsuitable. The optimal concentration of BPB is 4.12·10-4 M. To study the stability, the absorbance of the obtained solution was measured under optimal conditions for 45 min. The stoichiometric ratio of components in the resulting associate, determined by the method of continuous variations, is 1:1. The calibration graph is linear in the range from 4.1 to 33 μmol/L. The calculated LOD and LOQ values were 1.36 μmol/L and 4.13 μmol/L, respectively. The systematic error of the method is statistically insignificant in the whole range of calibration graph. The developed method was successfully applied for the determination of atorvastatin in tablets.

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Validation of Simultaneous Volumetric and HPLC Methods for the Determination of Pridinol Mesylate in Raw Material

Cited by 2 publications

References 5 publications

oncepts in development of fast, simple, stability indicating HPLC method for analysis of atorvastatin related compounds in tablets

oncepts in development of fast, simple, stability indicating HPLC method for analysis of atorvastatin related compounds in tablets

Development of the Spectrophotometric Method for the Determination of Atorvastatin Calcium in Tablets by using Bromophenol Blue

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