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2013•Northwest Pharmaceutical JournalRequires access

Determination of simvastatin and related substances in Simvastatin Capsules by RP-HPLC

Fan Liu

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Abstract

Objective To establish an RP-HPLC method for the determination of simvastatin and its related substances in Simvastatin Capsules.Methods An RP-HPLC method was developed.Chromatographic conditions included a Hypersil C18(250 mm× 4.6mm,5μm)colunm with the mobile phase of 0.25g·L-1 sodium phosphate dibasic anhydrous(pH=4.5)-acetonitrile(35∶65).The UV detection wavelength was set at 238nm.Results The linearity was good in the range of 40-160μg·mL-1(r=0.999 7,n=7).The recoveries were 99.25%-100.47%(n=9)and 99.26%-100.56%(n=9)with RSD 1.14%-1.94% and 1.03%-2.36%.The peaks of simvastatin and its related substances were separated completely.The limit of determination was 0.2ng.Conclusion This simple and reliable method can be applied to quantify Simvastatin Capsules and its related substances,and can be used to control the quality of Simvastatin Capsules.

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What this paper is about

Objective To establish an RP-HPLC method for the determination of simvastatin and its related substances in Simvastatin Capsules.Methods An RP-HPLC method was developed.Chromatographic conditions included a Hypersil C18(250 mm× 4.6mm,5μm)colunm with the mobile phase of 0.25g·L-1 sodium phosphate dibasic anhydrous(pH=4.5)-acetonitrile(35∶65).The UV detection wavelength was set at 238nm.Results The linearity was good in the range of 40-160μg·mL-1(r=0.999 7,n=7).The recoveries were 99.25%-100.47%(n=9)and 99.26%-100.56%(n=9)with RSD 1.14%-1.94% and 1.03%-2.36%.The peaks of simvastatin and its related substances were separated completely.The limit of determination was 0.2ng.Conclusion This simple and reliable method can be applied to quantify Simvastatin Capsules and its related substances,and can be used to control the quality of Simvastatin Capsules.

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Available abstract

Objective To establish an RP-HPLC method for the determination of simvastatin and its related substances in Simvastatin Capsules.Methods An RP-HPLC method was developed.Chromatographic conditions included a Hypersil C18(250 mm× 4.6mm,5μm)colunm with the mobile phase of 0.25g·L-1 sodium phosphate dibasic anhydrous(pH=4.5)-acetonitrile(35∶65).The UV detection wavelength was set at 238nm.Results The linearity was good in the range of 40-160μg·mL-1(r=0.999 7,n=7).The recoveries were 99.25%-100.47%(n=9)and 99.26%-100.56%(n=9)with RSD 1.14%-1.94% and 1.03%-2.36%.The peaks of simvastatin and its related substances were separated completely.The limit of determination was 0.2ng.Conclusion This simple and reliable method can be applied to quantify Simvastatin Capsules and its related substances,and can be used to control the quality of Simvastatin Capsules.

Key concepts: Simvastatin, Chromatography, Chemistry, High-performance liquid chromatography, Anhydrous, Detection limit, Acetonitrile, Pharmacology

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