Development of a procedure for the quantification of Sildenafil citrate in tablets by high performance liquid chromatography (HPLC)

Abstract

     This study helps constructing the optimal quantitative method for the determination of Sildenafil citrate content in Viagra film-coated tablets (Pfizer). The analyte was completely separated and quantified with a PDA probe (230 nm detection wavelength) using a combination of 60 % Methanol and 30 % Acetonitrile and 10 % Water as the mobile phase. This quantitative method provides better recovery and lower standard deviation (%RSD) as well as high accuracy compared to previous methods. Systematic fit with RSD% for retention time and the peak area is 0.69 % and 0.13 %, respectively. The specificity is satisfactory according to the ICH standard, Linear equation: y = 11997x - 25221 (R² = 0.9998) and the parameters are satisfied and in the linear range. Accuracy has RSD % retention time, peak area corresponding to 0.22; 1.60 %. Recovery rate:                 (98 to 102) % and RSD% ≤ 2 % meet the general requirements of the correctness assessment. With the application of these methods, the quantity control process shall be possible, ensuring the safety of the drug.