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Development of RP-HPLC Method for Separation of Atorvastatin Calcium, Amlodipine Besylate and Azilsartan Medoxomil and its Application to Analyze their Tablet Dosage Forms


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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 separation amlodipine besylate in presence of azilsartan medoxomil and atorvastatin calciumand estimation in their respective combined dosage forms. The chromatographic separation was achieved on C18 column (250×4.6 mm, 5 μ) using Acetonitrile: 20 mM Phosphate buffer (pH 3) 60:40 v/v as a mobile phase at flow rate of 0.8 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-amlodipine besylate and amlodipine besylate-azilsartan medoxomil in tablet formulations.

Keywords

Amlodipine Besylate, Azilsartan Medoxomil, Atorvastatin Calcium, RP-HPLC, Analytical Method Validation.
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  • Development of RP-HPLC Method for Separation of Atorvastatin Calcium, Amlodipine Besylate and Azilsartan Medoxomil and its Application to Analyze their Tablet Dosage Forms

Abstract Views: 268  |  PDF Views: 6

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 Chhaajed
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 separation amlodipine besylate in presence of azilsartan medoxomil and atorvastatin calciumand estimation in their respective combined dosage forms. The chromatographic separation was achieved on C18 column (250×4.6 mm, 5 μ) using Acetonitrile: 20 mM Phosphate buffer (pH 3) 60:40 v/v as a mobile phase at flow rate of 0.8 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-amlodipine besylate and amlodipine besylate-azilsartan medoxomil in tablet formulations.

Keywords


Amlodipine Besylate, Azilsartan Medoxomil, Atorvastatin Calcium, RP-HPLC, Analytical Method Validation.