Rulin Wang1, Yuan Tian1, Lin Zhang1, Zunjian Zhang1,2. 1. Key Laboratory of Drug Quality Control & Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing 210009, China. 2. State Key Laboratory of Natural Medicine, China Pharmaceutical University, Nanjing 210009, China.
Abstract
BACKGROUND: Levonorgestrel (LNG) is a commonly used emergency contraceptive which can effect sex hormone levels in female blood. The objective of this study was to develop and validate a specific and sensitive LC-MS/MS method for monitoring endogenous sex hormone levels (17β-estradiol and progesterone) in female plasma after administration of LNG. Results & methodology: The method was developed, optimized and validated according to the EMA guideline. Assay validation met all the criteria, including good linearity in the range of 0.1-20 ng/ml for 17β-estradiol, as well as 0.2-30 ng/ml for LNG and progesterone. CONCLUSION: The method has been preliminarily applied to explore the variation trend of sex hormone levels in healthy Chinese female volunteers' plasma after oral administration of 1.5 mg LNG tablet. With LNG absorption into plasma, progesterone and estradiol levels descended rapidly, and maintained at low levels in the onset time.
BACKGROUND:Levonorgestrel (LNG) is a commonly used emergency contraceptive which can effect sex hormone levels in female blood. The objective of this study was to develop and validate a specific and sensitive LC-MS/MS method for monitoring endogenous sex hormone levels (17β-estradiol and progesterone) in female plasma after administration of LNG. Results & methodology: The method was developed, optimized and validated according to the EMA guideline. Assay validation met all the criteria, including good linearity in the range of 0.1-20 ng/ml for 17β-estradiol, as well as 0.2-30 ng/ml for LNG and progesterone. CONCLUSION: The method has been preliminarily applied to explore the variation trend of sex hormone levels in healthy Chinese female volunteers' plasma after oral administration of 1.5 mg LNG tablet. With LNG absorption into plasma, progesterone and estradiol levels descended rapidly, and maintained at low levels in the onset time.
Entities:
Keywords:
LC–MS/MS; bioanalytical; emergency contraceptive; endogenous sex hormones; specificity
Authors: Steven W Blue; Andrea J Winchell; Amy V Kaucher; Rachel A Lieberman; Christopher T Gilles; Maria N Pyra; Renee Heffron; Xuanlin Hou; Robert W Coombs; Kavita Nanda; Nicole L Davis; Athena P Kourtis; Joshua T Herbeck; Jared M Baeten; Jairam R Lingappa; David W Erikson Journal: Contraception Date: 2018-01-31 Impact factor: 3.375
Authors: Lauren R Cirrincione; Sujan Dilly Penchala; Kimberly K Scarsi; Anthony T Podany; Lee C Winchester; David J Back; Saye H Khoo; Courtney V Fletcher; Marco Siccardi; Laura J Else Journal: J Chromatogr B Analyt Technol Biomed Life Sci Date: 2018-03-12 Impact factor: 3.205
Authors: Juan Pablo Del Río; María I Alliende; Natalia Molina; Felipe G Serrano; Santiago Molina; Pilar Vigil Journal: Front Public Health Date: 2018-05-23