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
Keywords
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