Mon, 18 Dec 2017

A Stability Indicating RP-UPLC method for Simultaneous Determination of Sildenafil and Tadalafil in Bulk Drugs and Pharmaceutical Dosage Forms.

 

Srihari Molleti1*, M. V. V. Suri Babu1, Vinay Rao2, K. N. Jayaveera3

1. Daewoong pharmaceuticals India private limited, Balanagar, Hyderabad India.

2. Malla reddy college of pharmacy, Hyderabad

3. Department of chemistry, JNT University, Anantapur. India.


 

ABSTRACT

This study is aimed at Developing and validating an UPLC method for determination of Sildenafil and tadalafil content in API and formulations. A chromatographic system consisting Waters  Acquity UPLC BEH C8(1.8 µm)column, mobile phase of  0.2 M ammonium acetate and Acetonitrile with gradient elution at flow of 0.3 mL/min and UV detector set at 245 nm has shown a good chromatographic separation for Sildenafil tadalafil. The developed method was validated as per ICH Guidelines, the developed UPLC method has run time of only 10 minutes making the method productive and tested by spiking all the impurities of sildenafil and tadalafil. It may be applied for Quality control Testing.


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