Abstract
A simple, easy-to-implement, and green infrared spectroscopic method was developed and validated for the quantitative determination of sildenafil citrate in tablets of unknown manufacturing formula. Homogenized tablet powder with known mass content (%, m/m) of sildenafil citrate was mixed with paracetamol to form standard mixtures with different percentages of sildenafil citrate on the total quantity of sildenafil citrate and paracetamol (designated as R). Unknown tablet samples were finely ground and mixed with paracetamol to form test mixtures having R values about 50%. Infrared spectra of standard mixtures, measured in attenuated total reflectance mode, in the wavenumber zone from 1800 cm−1 to 1300 cm−1 were selected and processed by partial least square regression to form the calibration model for quantitation of sildenafil citrate in unknown samples. Spectral responses of test mixtures and the calibration model were used to determine the exact mass content (%, m/m) of sildenafil citrate in the powder of unknown tablet samples. The method was fully validated in terms of linearity, precision, and accuracy according to the requirements of current guidelines and was proved as reliable and suitable for the intended application.
Highlights
Sildenafil, usually used in form of citrate salt, is a phosphodiesterase-5 (PDE-5) inhibitor widely used for the treatment of erection disorder [1]
Twenty Siloflam tablets randomly selected from the N532 batch were finely ground and mixed to homogenize to form the stock standard material. e exact mass content of sildenafil citrate in stock standard material was quantified against reference standard by using the HPLC method described in 2.4.1
Quantitation results by HPLC revealed that stock standard material contained 37.64% (m/m) sildenafil citrate. is value was employed to calculate the R values of working standard mixtures
Summary
Sildenafil, usually used in form of citrate salt, is a phosphodiesterase-5 (PDE-5) inhibitor widely used for the treatment of erection disorder [1]. In Vietnam, products containing sildenafil are currently commercialized under many different brand names and mostly in tablet form, and the use of these products is largely depending on the personal need of users and not strictly controlled by obligated prescription [2]. With the limited available resource of drug quality control network, the use of conventional techniques like HPLC, which is reliable but time- and resource-consuming, for routine control of a large number of samples taken from the market is not the optimal solution [3, 4]. A more feasible approach is to use some alternative technique acceptably reliable but faster and less resource-consuming, preferably more friendly toward the environment, than HPLC for routine control of samples containing sildenafil taken from the market, reserving HPLC only for confirmative analysis of doubtful cases [5]. FTIR-ATR methods are fast and the spectra can be recorded directly on solid homogenized or liquid samples without the need for a time-consuming and complicated sample preparation process often necessary for conventional
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