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Quantification and Validation of Simvastatin and Ezetimibe in Bulk Drugs and Combined Dosage Form by Reverse Phase Liquid Chromatographic Method (RPLC)

Submitted by webadmin on Tue, 10/18/2016 - 17:27
Pharmaceutical Methods,2015,6,2,115-119.
Published:July 2015
Type:Original Article

Quantification and Validation of Simvastatin and Ezetimibe in Bulk Drugs and Combined Dosage Form by Reverse Phase Liquid Chromatographic Method (RPLC)

Nalini Kanta Sahoo1*, Madhusmita Sahu1, Veerachamy Alagarsamy1, Bollu Vijaya Lalitha2, Alok Kumar Moharana3 and Chinmaya Keshari Sahoo4

1MNR College of Pharmacy, Fasalwadi, Sangareddy, Medak, Telangana, India.

2Yalamarty Pharmacy College,Tarluwada,Anandapuram,Visakhapatnam,Andhra Pradesh, 530052, India.

3Omega College of Pharmacy, Ghatkesar, R.R. dist,Telangana,India.

4Department of Pharmaceutics, Osmania University College of Technology, Osmania University,Hyderabad,Telangana-500007, India.

Abstract:

A simple, time saving, precise and cost effective reverse phase high performance liquid chromatographic (RP-HPLC) method developement was achieved for the determination and estimation of simvastatin and ezetimibe in its pure form and combined formulation. Separation was achieved by using Zorbax (100 × 4.6 mm, 5μ) C18 column with mobile phase consisted of acetonitrile and methanol in a ratio of 60:40 (v/v). The separation was observed at 232 nm with flow rate adjusted to 1 ml/min .simvastatin and ezetimibe were retained at 9.603 and 3.861 minutes successively. Validation was done for the developed method based upon different parameters like linearity, accuracy, precision, limit of detection and limit of quantitation. Simvastatin and ezetimibe obey Beer-Lambert’s law in the range of 20.0-160 μg/ml and 5-40 μg/ml respectively. The % recoveries of simvastatin and ezetimibe were found to be 101.25% and 102.03% respectively from the tablet formulation. The limit of detection of simvastatin and ezetimibe were found to be 1.34 μg/ml and 0.253 μg/ml successively. The limit of quantitation of simvastatin and ezetimibe were found to be 4.489 μg/ ml and 0.846 μg/ml successively. The established method is suitable for simultaneous estimation of simvastatin and ezetimibe in their pure forms and combined formulation.

Structure of Simvastatin