Asian Journal of Pharmaceutical Analysis

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Development of a RP-HPLC Method for Separation of Ezetimibe in Presence of Atorvastatin Caclium and Simvastatin and its Application for Qunatitation of Tablet Dosage Forms


Affiliations
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, India
     

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A single, simple, accurate and precise RP-HPLC method has been developed for the estimation of ezetimibe in presence of atorvastatin calcium and simvastatin in bulk and marketed combined formulations. The chromatographic separation was achieved on C18 column (250 × 4.6 mm, 5 μ) using Acetonitrile: water 70:30 v/v as a mobile phase at flow rate of 1.2 mL/min. The separation was achieved in isocratic mode and the detection was performed at 242 nm. Further the developed method was validated as per the ICH Q2 (R1) and applied for quantitation of atorvastatin calcium-ezetimibe and ezetimibe – simvastatin in tablet formulations.

Keywords

Ezetimibe, Simvastatin, Atorvastatin Calcium, RP-HPLC, Analytical Method Validation.
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  • Development of a RP-HPLC Method for Separation of Ezetimibe in Presence of Atorvastatin Caclium and Simvastatin and its Application for Qunatitation of Tablet Dosage Forms

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Authors

Kavita Wagh
MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, India
Sandeep Sonawane
MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, India
Santosh Chhajad
MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, India
Sanjay Kshirsagar
MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, India

Abstract


A single, simple, accurate and precise RP-HPLC method has been developed for the estimation of ezetimibe in presence of atorvastatin calcium and simvastatin in bulk and marketed combined formulations. The chromatographic separation was achieved on C18 column (250 × 4.6 mm, 5 μ) using Acetonitrile: water 70:30 v/v as a mobile phase at flow rate of 1.2 mL/min. The separation was achieved in isocratic mode and the detection was performed at 242 nm. Further the developed method was validated as per the ICH Q2 (R1) and applied for quantitation of atorvastatin calcium-ezetimibe and ezetimibe – simvastatin in tablet formulations.

Keywords


Ezetimibe, Simvastatin, Atorvastatin Calcium, RP-HPLC, Analytical Method Validation.

References