A tiered analytical approach for investigating poor quality emergency contraceptives

Reproductive health has been deleteriously affected by poor quality medicines. Emergency contraceptive pills (ECPs) are an important birth control method that women can use after unprotected coitus for reducing the risk of pregnancy. In response to the detection of poor quality ECPs commercially ava...

Full description

Bibliographic Details
Main Authors: Monge, M, Dwivedi, P, Zhou, M, Payne, M, Harris, C, House, B, Juggins, Y, Cizmarik, P, Newton, P, Fernández, F, Jenkins, D
Format: Journal article
Language:English
Published: Public Library of Science 2014
_version_ 1797078411754078208
author Monge, M
Dwivedi, P
Zhou, M
Payne, M
Harris, C
House, B
Juggins, Y
Cizmarik, P
Newton, P
Fernández, F
Jenkins, D
author_facet Monge, M
Dwivedi, P
Zhou, M
Payne, M
Harris, C
House, B
Juggins, Y
Cizmarik, P
Newton, P
Fernández, F
Jenkins, D
author_sort Monge, M
collection OXFORD
description Reproductive health has been deleteriously affected by poor quality medicines. Emergency contraceptive pills (ECPs) are an important birth control method that women can use after unprotected coitus for reducing the risk of pregnancy. In response to the detection of poor quality ECPs commercially available in the Peruvian market we developed a tiered multi-platform analytical strategy. In a survey to assess ECP medicine quality in Peru, 7 out of 25 different batches showed inadequate release of levonorgestrel by dissolution testing or improper amounts of active ingredient. One batch was found to contain a wrong active ingredient, with no detectable levonorgestrel. By combining ultrahigh performance liquid chromatography-ion mobility spectrometry-mass spectrometry (UHPLC-IMS-MS) and direct analysis in real time MS (DART-MS) the unknown compound was identified as the antibiotic sulfamethoxazole. Quantitation by UHPLC-triple quadrupole tandem MS (QqQ-MS/MS) indicated that the wrong ingredient was present in the ECP sample at levels which could have significant physiological effects. Further chemical characterization of the poor quality ECP samples included the identification of the excipients by 2D Diffusion-Ordered Nuclear Magnetic Resonance Spectroscopy (DOSY 1H NMR) indicating the presence of lactose and magnesium stearate.
first_indexed 2024-03-07T00:31:37Z
format Journal article
id oxford-uuid:7ffde36d-1666-45e0-a63f-b474608e15d7
institution University of Oxford
language English
last_indexed 2024-03-07T00:31:37Z
publishDate 2014
publisher Public Library of Science
record_format dspace
spelling oxford-uuid:7ffde36d-1666-45e0-a63f-b474608e15d72022-03-26T21:20:34ZA tiered analytical approach for investigating poor quality emergency contraceptivesJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:7ffde36d-1666-45e0-a63f-b474608e15d7EnglishSymplectic Elements at OxfordPublic Library of Science2014Monge, MDwivedi, PZhou, MPayne, MHarris, CHouse, BJuggins, YCizmarik, PNewton, PFernández, FJenkins, DReproductive health has been deleteriously affected by poor quality medicines. Emergency contraceptive pills (ECPs) are an important birth control method that women can use after unprotected coitus for reducing the risk of pregnancy. In response to the detection of poor quality ECPs commercially available in the Peruvian market we developed a tiered multi-platform analytical strategy. In a survey to assess ECP medicine quality in Peru, 7 out of 25 different batches showed inadequate release of levonorgestrel by dissolution testing or improper amounts of active ingredient. One batch was found to contain a wrong active ingredient, with no detectable levonorgestrel. By combining ultrahigh performance liquid chromatography-ion mobility spectrometry-mass spectrometry (UHPLC-IMS-MS) and direct analysis in real time MS (DART-MS) the unknown compound was identified as the antibiotic sulfamethoxazole. Quantitation by UHPLC-triple quadrupole tandem MS (QqQ-MS/MS) indicated that the wrong ingredient was present in the ECP sample at levels which could have significant physiological effects. Further chemical characterization of the poor quality ECP samples included the identification of the excipients by 2D Diffusion-Ordered Nuclear Magnetic Resonance Spectroscopy (DOSY 1H NMR) indicating the presence of lactose and magnesium stearate.
spellingShingle Monge, M
Dwivedi, P
Zhou, M
Payne, M
Harris, C
House, B
Juggins, Y
Cizmarik, P
Newton, P
Fernández, F
Jenkins, D
A tiered analytical approach for investigating poor quality emergency contraceptives
title A tiered analytical approach for investigating poor quality emergency contraceptives
title_full A tiered analytical approach for investigating poor quality emergency contraceptives
title_fullStr A tiered analytical approach for investigating poor quality emergency contraceptives
title_full_unstemmed A tiered analytical approach for investigating poor quality emergency contraceptives
title_short A tiered analytical approach for investigating poor quality emergency contraceptives
title_sort tiered analytical approach for investigating poor quality emergency contraceptives
work_keys_str_mv AT mongem atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT dwivedip atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT zhoum atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT paynem atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT harrisc atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT houseb atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT jugginsy atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT cizmarikp atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT newtonp atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT fernandezf atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT jenkinsd atieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT mongem tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT dwivedip tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT zhoum tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT paynem tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT harrisc tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT houseb tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT jugginsy tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT cizmarikp tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT newtonp tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT fernandezf tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives
AT jenkinsd tieredanalyticalapproachforinvestigatingpoorqualityemergencycontraceptives