STABILITY-INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR ANALYZING INJECTION DOSAGE FORMULATION CONTAINING MEDROXYPROGESTERONE ACETATE AND ESTRADIOL CYPIONATE
Keywords:Medroxyprogesterone acetate,, Estradiol cypionate,, Contraceptive,, Quantitation,, Stress test
Objective: Stability-indicating reversed-phase high-performance liquid chromatography method with photodiode array detection is described for the assay of medroxyprogesterone acetate (MDA) and estradiol cypionate (ECA) in bulk and injection dosage form.
Methods: MDA and ECA were determined on a Cosmicsil (250 mm × 4 mm) C18, 5 μm analytical column using mobile phase of 0.1 M KH2PO4 and acetonitrile (65:35 v/v) supplied isocratically by a flow rate of 1 ml/min. During stress testing, the sample was subjected to stress with 0.1 N HCl, 0.1 N NaOH, 30% hydrogen peroxide, water, and 105°C in oven and sunlight. Method validation was done in accordance with international conference on harmonization.
Results: The linear response was obtained over the concentration range from 2.5 to 7.5 μg/ml for ECA and 12.5 to 37.50 μg/ml for MDA. The recoveries of MDA and ECA were 99.31%–99.45% and 99.59%–99.79%, with relative standard deviation ranging from 0.021% to 0.217% and 0.027% to 0.187%, respectively. The limits of detection for MDA and ECA were 0.097 μg/ml and 0.042 μg/ml, respectively. The method was able to selectively quantitate MDA and ECA in the presence of the degradation products and, hence, can be considered as stability-indicating one. Proposed method was applied to the quantification of MDA and ECA in injection dosage form with good precision and accuracy.
Conclusion: The method can be employed for routine and quality control analysis of MDA and ECA simultaneously.
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