Pradeep Gautam
201 W. 5th St. Suite 1250, Austin, TX 78701
Tanzania
Research Article
Method Development and Validation of Stability Indicating RP-HPLC Method
for the Determination of Female Hormones in Hormone Concentrates
Creams
Author(s): Pradeep GautamPradeep Gautam
A rapid, novel, and efficient stability indicating reverse-phase high performance liquid chromatographic (RPHPLC) analytical method was developed and validated for the determination of four female hormones: Progesterone, Estrone, Estradiol, and Estriol in Hormones Concentrate compounding bases. Separation was achieved with a RP- C18 Phenomenex® Gemini 150 × 4.6 mm C18 5µm column using a phosphate buffer pH 6.4 and acetonitrile. The developed HPLC method was validated with method validation components: linearity, accuracy, precision, intermediate precision, and robustness. Limit of detection (LOD) and limit of quantification (LOQ) were also obtained for all four hormones for this method. Photodiode array (PDA) detector was set up at 225 nm wavelength for the simultaneous analysis of all four peaks. Hormone concentrate samples, placebo, and hormone actives were subjected.. View More»
