STABILITY-INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR ANALYZING INJECTION DOSAGE FORMULATION CONTAINING MEDROXYPROGESTERONE ACETATE AND ESTRADIOL CYPIONATE

SARAVANAN CHANDRAN; XAVIER RAJARATHINAM SR; ANANDAN KALAISELVAN

doi:10.22159/ajpcr.2019.v12i6.32599

Authors

SARAVANAN CHANDRAN Research and Development Centre, Bharathiar University, Coimbatore, Tamil Nadu, India.
XAVIER RAJARATHINAM SR Research and Development Centre, Bharathiar University, Coimbatore, Tamil Nadu, India.
ANANDAN KALAISELVAN Research and Development Centre, Bharathiar University, Coimbatore, Tamil Nadu, India.

DOI:

https://doi.org/10.22159/ajpcr.2019.v12i6.32599

Keywords:

Medroxyprogesterone acetate,, Estradiol cypionate,, Contraceptive,, Quantitation,, Stress test

Abstract

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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