DEVELOPMENT AND VALIDATION OF STABILITY INDICATING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR ESTIMATION OF LEVONORGESTREL IN BULK DOSAGE FORM
Keywords:
Levonorgestrel, RP-HPLC, Stability indicating, Validation, RecoveryAbstract
A stability-indicating RP-HPLC method was developed and validated for the determination of Levonorgestrel in bulk dosage forms using Phenomenex C18 column (250 mm × 4.6 mm id, 5 ?m particle size) as stationary phase; acetonitrile: water (80:20, v/v) as a mobile phase with flow rate of 1.0 ml/min. Quantification was achieved with Photo Diode Array detector at 241 nm. The retention time for Levonorgestrel was found to be 2.47 min. The linearity was obtained in the concentration range of 1-12 µg/ml for Levonorgestrel. Levonorgestrel was subjected to stress conditions including acidic, alkaline, oxidative, thermal, UV radiation and sunlight degradation conditions. Levonorgestrel was found more sensitive towards acidic, alkaline and oxidative degradations. The method was validated as per ICH guidelines.
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