title: Stability behaviour of antiretroviral drugs and their combinations. 3: Characterization of interaction products of emtricitabine and tenofovir disoproxil fumarate by mass spectrometry.
abstract: The present study investigated drug-drug interaction behaviour of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) under solid state stability test conditions. Six interaction products were separated and detected by high performance liquid chromatography coupled to photodiode array detector (HPLC-PDA) using C18 column. The same were characterized using LC-high resolution mass spectrometry (LC-HRMS), LC-multi stage mass spectrometry (LC-MS(n)) and online hydrogen/deuterium (H/D) exchange studies. The interaction pathway among the two drugs was outlined based on the elucidated structures. Four of the six interaction products were also formed in marketed tablets containing FTC and TDF (along with efavirenz (EFV)) that were kept without packing under accelerated condition of 40°C/75% RH till 6 months.
authors.affiliation: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar 160 062, Punjab, India.
authors.forename: Moolchand
authors.initials: M
authors.lastname: Kurmi
authors.affiliation: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar 160 062, Punjab, India.
authors.forename: Dilip Kumar
authors.initials: DK
authors.lastname: Singh
authors.affiliation: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar 160 062, Punjab, India.
authors.forename: Shristy
authors.initials: S
authors.lastname: Tiwari
authors.affiliation: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar 160 062, Punjab, India.
authors.forename: Parul
authors.initials: P
authors.lastname: Sharma
authors.affiliation: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar 160 062, Punjab, India. Electronic address: ssingh@niper.ac.in.
authors.forename: Saranjit
authors.initials: S
authors.lastname: Singh
mesh_terms: D000480:Alkynes; D044966:Anti-Retroviral Agents / Q000737:chemistry; D048588:Benzoxazines / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D003521:Cyclopropanes; D004347:Drug Interactions; D004355:Drug Stability; D000068679:Emtricitabine / Q000031:analogs & derivatives / Q000737:chemistry*; D013058:Mass Spectrometry; D015394:Molecular Structure; D013607:Tablets / Q000737:chemistry; D000068698:Tenofovir / Q000031:analogs & derivatives / Q000737:chemistry*
chemical_list: D000480:Alkynes; D044966:Anti-Retroviral Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D013607:Tablets; D000068698:Tenofovir; D000068679:Emtricitabine; C098320:efavirenz
keywords: Emtricitabine; Interaction products; Mass spectrometry; Solid state stress; Tenofovir disoproxil fumarate