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Validated RP-HPLC Method for the Simultaneous Estimation of Simvastatin and Niacin


Affiliations
1 Department of Pharmaceutical Chemistry, Procadence Institute of Pharmaceutical Sciences, Rimmanaguda, Gajwel, Medak (Dt)-502312, Telangana, India
2 Department of Pharmaceutical Analysis, Procadence Institute of Pharmaceutical Sciences, Rimmanaguda, Gajwel, Medak (Dt)-502312, Telangana, India
3 Department of Pharmacology, Procadence Institute of Pharmaceutical Sciences, Rimmanaguda, Gajwel, Medak (Dt)-502312, Telangana, India
     

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A simple, accurate, precise, rapid and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Simvastatin and Niacin in Pure and Tablet dosage forms. Inertsil ODS, RP-18 Column (250×4.6 mm ID, 5μ) was used with a mobile phase containing a mixture of Phosphate buffer pH 2.5, Methanol and Acetonitrile in the ratio of 45:20:35. The procedure was carried out at pH-3.5. The compounds were eluted at a flow rate of 1.0 ml/min. results were determined at 220 nm with fixed wavelength PDA detector. The linearity for Niacin was found between 75-175 μg/ml and between 3-7 μg/ml for Simvastatin. The retention times were found as 4.747 min and 2.970 min for Niacin and Simvastatin respectively. The above method was validated in terms of System suitability, linearity, accuracy, precision, Limit of Detection (LOD), Limit of Quantification (LOQ), Robustness in accordance with ICH guidelines. The method was rapid, simple, economical and suitable for routine quality control analysis.

Keywords

Simvastatin, Niacin, Method Development, Validation, RP-HPLC.
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  • Validated RP-HPLC Method for the Simultaneous Estimation of Simvastatin and Niacin

Abstract Views: 180  |  PDF Views: 3

Authors

Ganesh Akula
Department of Pharmaceutical Chemistry, Procadence Institute of Pharmaceutical Sciences, Rimmanaguda, Gajwel, Medak (Dt)-502312, Telangana, India
Bollaboina Venkatesh
Department of Pharmaceutical Analysis, Procadence Institute of Pharmaceutical Sciences, Rimmanaguda, Gajwel, Medak (Dt)-502312, Telangana, India
K. Sanjayraj
Department of Pharmaceutical Analysis, Procadence Institute of Pharmaceutical Sciences, Rimmanaguda, Gajwel, Medak (Dt)-502312, Telangana, India
S. S. Phanindra
Department of Pharmaceutical Analysis, Procadence Institute of Pharmaceutical Sciences, Rimmanaguda, Gajwel, Medak (Dt)-502312, Telangana, India
A. Jaswanth
Department of Pharmacology, Procadence Institute of Pharmaceutical Sciences, Rimmanaguda, Gajwel, Medak (Dt)-502312, Telangana, India

Abstract


A simple, accurate, precise, rapid and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Simvastatin and Niacin in Pure and Tablet dosage forms. Inertsil ODS, RP-18 Column (250×4.6 mm ID, 5μ) was used with a mobile phase containing a mixture of Phosphate buffer pH 2.5, Methanol and Acetonitrile in the ratio of 45:20:35. The procedure was carried out at pH-3.5. The compounds were eluted at a flow rate of 1.0 ml/min. results were determined at 220 nm with fixed wavelength PDA detector. The linearity for Niacin was found between 75-175 μg/ml and between 3-7 μg/ml for Simvastatin. The retention times were found as 4.747 min and 2.970 min for Niacin and Simvastatin respectively. The above method was validated in terms of System suitability, linearity, accuracy, precision, Limit of Detection (LOD), Limit of Quantification (LOQ), Robustness in accordance with ICH guidelines. The method was rapid, simple, economical and suitable for routine quality control analysis.

Keywords


Simvastatin, Niacin, Method Development, Validation, RP-HPLC.