DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ETHINYL ESTRADIOL AND LEVONORGESTREL
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 3
Abstract
ABSTRACT A simple, accurate, precise, sensitive, specific and reliable stability indicating RP-HPLC method was developed for simultaneous estimation of Ethinyl estradiol (EE) and Levonorgestrel (LEV) in Pharmaceutical dosage form. The developed method with mobile phase Acetonitrile: Water (75: 25), Analytica brownee C-18 (150×4.6 mm, 3μm particle size) as a stationary phase and flow rate was 0.8 ml/min. Detection was carried out at 230 nm in PDA detector. The calibration curve of Ethinyl estradiol and Levonorgestrel was found to be linear in the range of 4-14 μg/ml and 20-70 μg/ml respectively. The proposed method has been validated for precision, accuracy, robustness. As the proposed method can effectively separate the drugs from all their degradation products, it can be employed as stability indicating method. Keywords: Ethinyl estradiol, Levonorgestrel, High Performance Liquid chromatography, Validation.
Authors and Affiliations
*Tejal Rathod and Anandkumari D. Captain
AN OVERVIEW ON HIGH PERFORMANCE LIQUIDCHROMATOGRAPHY- MASS SPECTROSCOPY
ABSTRACT Ultra high performance liquid chromatography\ms is an extremely versatile instrumental technique. As the name suggested the instrumentation comprises a high performance liquid chromatography attached, via...
RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF OLANZAPINE AND FLUOXETINE IN TABLET DOSAGE FORM
ABSTRACT A new precise, accurate, reliable validated method for the determination of Olanzapine and Fluoxetine has been developed by using reverse phase high performance liquid chromatography (RP-HPLC) in pharma...
MICELLAR ELECTROKINETIC CHROMATOGRAPHY: AN OVERVIEW
ABSTRACT Micellar electrokinetic chromatography (MEKC) is a useful branch of capillary electrophoresis (CE) that utilizes surfactant above critical micellar concentration (CMC) as pseudo-stationary phase. MEKC c...
RECENT APPROCHES FOR IMPURITY PROFILING IN PHARMACEUTICAL FORMULATIONS
ABSTRACT In the pharmaceutical world, an impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. The...
DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF CEFTAROLINE FOSAMIL IN BULK AND INJECTION FORM
ABSTRACT Two simple, sensitive, specific, spectrophotometric methods have been developed for the determination of ceftaroline fosamil in bulk and Injection forms. The λmax of ceftaroline fosamil was found to be 2...