RP-HPLC Method Development and Validation for the Simultaneous estimation of Simvastatin and Ezetimibe in Tablet Dosage Form

Authors

  • Mohammed. Ibrahim
  • K.Rajeswar dutt
  • Vadthya Rajashekar

DOI:

https://doi.org/10.61096/ijpar.v3.iss1.2014.83-91

Keywords:

Simvastatin, Ezetimibe, RP-HPLC, Validation

Abstract

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and
validated for simultaneous determination of Simvastatin and Ezetimibe in pharmaceutical tablet dosage form.
Chromatographic analysis was performed on a Symmetry C8 (4.6mm x 150mm, 5m) column at ambient
temperature with a mixture of ortho phosphoric acid buffer and Acetonitrile in the ratio 40:60 v/v (Ortho
phosphoric acid buffer preparation; Take 1000ml of HPLC grade water and 1 ml orthophosphoric acid and pH
adjusted) as mobile phase, at a flow rate of 1.0 mL min-1
. UV detection was performed at 221 nm. The method
was validated for accuracy, precision, specificity, linearity and sensitivity. The retention times of Simuvastatin
and Ezetimibe were 2.190 and 3.515 min, respectively. Calibration plots were linear over the concentration
ranges 10–50 μg mL-1
and 10-50 μg mL-1
for Simvastatin and Ezetimibe, respectively. The Limit of detection
was 2.0 and 6.31µg mL-1
and the quantification limit were 6.31 µg mL-1
and 2.99 µg mL-1 for Simvastatin and
Ezetimibe, respectively. The accuracy of the proposed method was determined by recovery studies and found to
be 99.98% to 101.21%..

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Published

2014-01-06

How to Cite

Mohammed. Ibrahim, K.Rajeswar dutt, & Vadthya Rajashekar. (2014). RP-HPLC Method Development and Validation for the Simultaneous estimation of Simvastatin and Ezetimibe in Tablet Dosage Form. IJPAR JOURNAL, 3(1), 83–91. https://doi.org/10.61096/ijpar.v3.iss1.2014.83-91