Asian Journal of Pharmaceutical Analysis

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Development and Validation of RP-HPLC Method for Simultaneous Estimation of Ezetimibe and Glimepiride in Tablet Dosage Form


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1 MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 42200, India
     

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A simple, accurate and precise RP-HPLC method was developed and validated for simultaneous estimation of glimepiride (GLM) and ezetimibe (EZE) in tablet dosage form. Both drugs were separated on C18 Phenomenex column (250 × 4.6 mm, 5 μ) using methanol: 20mM potassium phosphate buffer (pH 3.00) (80: 20 % v/v) at flow rate of 1 mL/min. All eluents were detected at 230 nm. GLM and EZE were eluted at 5.292 and 4.183 min, respectively. The method was linear in the range of 2-10 μg/mL and 20-100 μg/mL for GLM and EZE, respectively. The developed method was further validated as per ICH Q2(R1) guidelines and applied successfully for the quantitation of tablet dosage form.

Keywords

Ezetimibe and Glimepiride, RP-HPLC, Analytical Method Validation.
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  • Development and Validation of RP-HPLC Method for Simultaneous Estimation of Ezetimibe and Glimepiride in Tablet Dosage Form

Abstract Views: 258  |  PDF Views: 0

Authors

Ashwini Parmar
MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 42200, India
Sandeep Sonawane
MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 42200, India
Santosh Chhajed
MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 42200, India
Sanjay Kshirsagar
MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 42200, India

Abstract


A simple, accurate and precise RP-HPLC method was developed and validated for simultaneous estimation of glimepiride (GLM) and ezetimibe (EZE) in tablet dosage form. Both drugs were separated on C18 Phenomenex column (250 × 4.6 mm, 5 μ) using methanol: 20mM potassium phosphate buffer (pH 3.00) (80: 20 % v/v) at flow rate of 1 mL/min. All eluents were detected at 230 nm. GLM and EZE were eluted at 5.292 and 4.183 min, respectively. The method was linear in the range of 2-10 μg/mL and 20-100 μg/mL for GLM and EZE, respectively. The developed method was further validated as per ICH Q2(R1) guidelines and applied successfully for the quantitation of tablet dosage form.

Keywords


Ezetimibe and Glimepiride, RP-HPLC, Analytical Method Validation.

References