DOI: 10.21276/ajptr
Tue, 21 May 2019

Determination of sildenafil citrate and its related substances in the commercial products and tablet dosage form using RP-UPLC.


Srihari Molleti*1, 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.



This study is aimed at Developing and validating an UPLC method for the related substances of Sildenafil that might coexist in tablet formulations as impurities that may originate from synthesis process or degradation. A chromatographic system consisting Waters  Acquity UPLC HSS C18(1.8 µm)column, mobile phase of  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 and its related substances. The developed method was validated as per ICH Guidelines and compared with Pharma Europa method. The pharmacopeia method has above 60 minutes runtime to separate all the listed related compounds, the developed UPLC method has run time of only 10 minutes making the method productive and may be applied for Quality control Testing.

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