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Original Articles

Phosphodiesterase-5 inhibitors and their analogues as adulterants of herbal and food products: analysis of the Malaysian market, 2014–16

, ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon
Pages 1101-1109 | Received 07 Feb 2017, Accepted 27 May 2017, Published online: 29 Jun 2017
 

ABSTRACT

Adulteration of herbal health supplements with phosphodiesterase-5 (PDE-5) inhibitors and their analogues is becoming a worldwide problem. The aim of this study was to investigate herbal and food products sold in the Malaysian market for the presence of these adulterants. Sixty-two products that claim to enhance men’s sexual health were sampled between April 2014 and April 2016. These products included unregistered products seized by the Pharmacy Enforcement Division of the Ministry of Health (n = 39), products sent to the National Pharmaceutical Regulatory Agency for pre-registration testing (n = 9) and products investigated under the post-registration market surveillance programme (n = 14). The products were tested against an in-house spectral library consisting of 61 PDE-5 inhibitors and analogues using a validated liquid chromatography-mass spectrometry ion-trap-time-of-flight (LC-MS IT-TOF) method. Thirty-two (82%) of the unregistered products and two (14%) of the registered products were found to be adulterated with at least one PDE-5 inhibitor or analogue, while none of the pre-registration products contained adulterants. A total of 16 different adulterants were detected and 36% of the adulterated products contained a mixture of two or more adulterants. This study has demonstrated that the adulteration of unregistered herbal products in the Malaysian market is an alarming issue that needs to be urgently addressed by the relevant authorities.

Acknowledgement

Special thanks to the National Pharmaceutical Regulatory Agency for providing standards and samples.

Disclosure statement

No potential conflict of interest was reported by the authors.​​

Supplemental data

Supplemental data for this article can be accessed here.

Additional information

Funding

This study was funded by a grant from the University of Malaya [grant number PG211-2015A].

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