A stability-indicating reversed-phase high-performance liquid chromatography method has been developed and validated for the assay of indiquinoline tartrate and its related substances. The method was established by forced degradation experiments and system suitability experiments. The chromatographic separation was achieved with a Hedera ODS-3 column (5 µm, 250 mm × 4.6 mm) and the mobile phase was constituted (flow rate 1.0 mL/min) of eluant A, aqueous acetate buffer and eluant B, CH(3)OH using a gradient elution. A photodiode array detector set at 254 nm was used for detection. The investigated validation elements showed that the method has acceptable specificity, accuracy, linearity, precision, robustness and high sensitivity with limit of detection and limit of quantitation. The method can be used for routine quality control analysis and stability testing of indiquinoline tartrate drug substance.
Phosphodiesterase type 5 inhibitors (PDE-5i) are the first-line medication for oral erectile dysfunction, which are used according to the prescription of doctors. However, these substances have been found illegally in supplementary foods. The quality and safety of dietary supplements for enhancing male sexual performance have been questioned, raising the need for continual development of analytical methods. Liquid chromatography coupled with high-resolution mass spectrometry has become one of the most effective methods to identify and measure PDE-5i concentration. In this research, we focused on (i) developing and validating an effective screening and quantitation method for more than 53 PDE-5i in ingredients and supplementary products using LC-Q-Exactive after a simple sample extraction and (ii) assessing PDE-5i content in natural-based supplementary products available in Vietnam market. The extraction method used a small amount of organic solvent, which makes it more environmentally friendly (greener). The developed method has a limit of detection of 0.4 mg/kg, a limit of quantitation of 1.2 mg/kg, recoveries from 80 to 110%, and repeatability lower than 15%. Ninety-two herbal supplementary foods and ingredients used for enhancement of male sexual performance available in Vietnamese markets were collected. Fourteen PDE-5i including conventional and novel analogous were detected and measured in eighteen food supplements and two formulation ingredient samples.
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