Research Journal of Pharmacy and Technology

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Separation and Quantification of Sacubitril-Valsartan Combination in Tablets by a New Ion-pair HPLC


Affiliations
1 Pharmaceutical Quality and Pharmaceutical Chemistry Department-University of Aleppo, Syrian Arab Republic
2 Laboratoire SPCMIB (UMR CNRS 5068), Université Paul Sabatier, Université de Toulouse, 118 route de Narbonne, 31062 Toulouse cedex, France
     

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The objective of this study was to develop and validate a new ion-pair reversed phase high performance liquid chromatographic method on a standard C18-type stationary phase with UV detection for the analysis of the recent two-drugs combination sacubitril/valsartan in tablets. The mobile phase consisted of a mixture of 45% of 10-3 M of cetyltrimethylammonium bromide (cetrimide) as the ion-pairing agent and 55% acetonitrile. The method validation was based on linearity, accuracy, precision, robustness and specificity. This method exhibits good linearity and accuracy with mean recovery values between 95.0-105.0%, precision with relative standard deviations of the calculated concentrations less than 5.0% and specificity in the presence of degradation products. These results indicates that the proposed method is simple and applicable for the separation and determination of sacubitril, valsartan combination in tablets and could be a relevant method to implement in quality control laboratories.

Keywords

HPLC, Ion Pair Liquid Chromatography, Sacubitril, Valsartan.
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  • Separation and Quantification of Sacubitril-Valsartan Combination in Tablets by a New Ion-pair HPLC

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Authors

Saleh Trefi
Pharmaceutical Quality and Pharmaceutical Chemistry Department-University of Aleppo, Syrian Arab Republic
Yaser Bitar
Pharmaceutical Quality and Pharmaceutical Chemistry Department-University of Aleppo, Syrian Arab Republic
Veronique Gilard
Laboratoire SPCMIB (UMR CNRS 5068), Université Paul Sabatier, Université de Toulouse, 118 route de Narbonne, 31062 Toulouse cedex, France

Abstract


The objective of this study was to develop and validate a new ion-pair reversed phase high performance liquid chromatographic method on a standard C18-type stationary phase with UV detection for the analysis of the recent two-drugs combination sacubitril/valsartan in tablets. The mobile phase consisted of a mixture of 45% of 10-3 M of cetyltrimethylammonium bromide (cetrimide) as the ion-pairing agent and 55% acetonitrile. The method validation was based on linearity, accuracy, precision, robustness and specificity. This method exhibits good linearity and accuracy with mean recovery values between 95.0-105.0%, precision with relative standard deviations of the calculated concentrations less than 5.0% and specificity in the presence of degradation products. These results indicates that the proposed method is simple and applicable for the separation and determination of sacubitril, valsartan combination in tablets and could be a relevant method to implement in quality control laboratories.

Keywords


HPLC, Ion Pair Liquid Chromatography, Sacubitril, Valsartan.

References