Cost Effective, Efficient and Stability indicating Method Development & Validation for determination of related substances for Levonorgestrel & Ethinyl Estradiol Tablets
Abstract
The objective of this research was to develop and validate a simple, specific and accurate reverse phase of high performance of liquid chromatographic method for the determination of levonorgestrel (LVG) and ethinylestradiol (EE) in tablets. The chromatographic system included column Sun Fire ODS (150 mm × 4.6 mm i.d., particle size at 5 μm), mobile phase consisting of acetonitrile: methanol: aquabidest (60:15:25) with the flow rate of 1 mL/minute and effluents monitored at 230 nm. The validation of RP HPLC method for the simultaneous determination of LVG and EE was determined by accuracy, precision, linearity, and limit of detection (LOD) as well as the limit of quantitation (LOQ) parameters. The linearity range of both drugs was 1-70 µg/mL and 2-14 µg/mL for LVG and EE, respectively. The recoveries of LVG and EE were at 101.78% and 102.44% with the coefficients of variation of 0.94% and 1.92%, successively. The LOD of LVG and EE value were of 0.84 µg/mL and 0.03 µg/mL, and LOQ value were of 2.79 and 0.09µg/mL, respectively.
Keywords: Levonorgestrel (LVG), Ethinylestradiol, Method Validation, Method Validation, HPLC
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