ISSN 2321–3647
Sat, 18 Nov 2017

Compatibility Method Validation of Medroxyprogesterone Acetate And Estradiol Cypionate Combination Drug In Injectable Suspension Dosage Forms

M. Sankar1*, S. Arulantony1, R. Gunshekhar2, K. Pavan Kumar3

1.Post Graduate and Research Department of Chemistry,Presidency College, Chepauk (TN), Chennai - 600 005, India

2.Department of Chemistry, Annamalai University, Chidambaram - 638001, TamilNadu- India

3. Department of Pharmaceutical Analysis, Nandha College of Pharmacy, KoorapalayamPiruvu, Erode-638052, TamilNadu, India


ABSTRACT

A simple RP-HPLC compatible method for the injectable suspension dosage of combined medroxyprogesterone acetate and estradiol cypionate was developed and validated according to ICH and USP guidelines. The chromatographic separation was achieved by using the Zorbax Eclipse C18 column (50 mm×4.6 mm, 2.7 µm) with gradient elution technique at a flow rate of 1.0 ml/min. The UV detection was performed at 225 nm. The linearity of medroxyprogesterone acetate over the concentration range was 49.65 to 744.69 μg/ml and 10.15 to 152.28 μg/ml for estradiol cypionate respectively. The accuracy was evaluated by means of spike recovery method and the result showed in the range of 99.7% to 101.4% for medroxyprogesterone acetate and 98.6% to 101.8% for estradiol cypionate. The specificity of the method showed that the analyte was not interfered by the presence of co-formulated substances. The robustness of the study was found agreeable; hence it proves that the method was robust. The stability of the analyte was found stable for 24 hours. The developed method was successfully employed for the determination of combined medroxyprogesterone acetate and estradiol cypionate in injectable suspension dosage forms.

Keywords: Medroxyprogesterone acetate, Estradiol cypionate, RP-HPLC, Validation


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