Determination of content uniformity of Sildenafil citrate orally disintegrating tablets
OBJECTIVE To determine the content uniformity of sildenafil citrate orally disintegrating tablets using UV spectrometry.METHODS The homogeneity of the content of sildenafil citrate orally disintegrating tablets was rapidly determined by UV spectrophotometer at the detection wavelength of 292 nm,using 0.01 mol·L-1 hydrochloric acid as solvent.RESULTS A good linear relationship was shown between the concentration of sildenafil citrate control and the absorbance in the range of 11.14-39.89 μg·mL-1.Its average recovery was 101.42％with RSD of 0.40％and the prepared sample solution was stable within 8 h.The content uniformity of the three batches of orally disintegrating tablets of sildenafil citrate was determined to be within the qualified range,with A+2.2S of 3.54,1.98,2.70,respectively.There was no significant difference compared with the HPLC method.CONCLUSION The method is simple,rapid,economical,reproducible and can be used for the determination of the uniformity of the content of sildenafil citrate orally disintegrating tablets.
Sildenafil citrateOrally disintegrating tabletsContent uniformityUltraviolet spectrophotometryHPLCPDE5Quality control
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