A stability-indicating HPLC method for medroxyprogesterone acetate in bulk drug and injection formulation.
A stability-indicating HPLC assay method has been developed and validated for medroxyprogesterone acetate (MPA) in bulk drug and injectable suspension. An isocratic RP-HPLC was achieved on a Hichrom C(18) column (150 mm x 4.6mm i.d., 5 microm) utilizing a mobile phase of methanol 0.020 M acetate buffer pH 5 (65:35, v/v) and a photodiode array detector at 245 nm. The stress testing of MPA was carried out under acidic and alkaline hydrolysis, and oxidation conditions. MPA was well resolved from its degradation products, a main related substance (megestrol acetate) and two preservatives (methyl paraben and propyl paraben) with the resolution >or=2. The proposed method was validated for selectivity, linearity, accuracy, precision and solution stability. The method was found to be suitable for the quality control of MPA in bulk drug and injections as well as the stability-indicating studies.
Burana-Osot
Jankana
J
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Silpakorn University, Sanamchandra Palace Campus, Nakhon Pathom 73000, Thailand. jankana@email.pharm.su.ac.th
Ungboriboonpisal
Sooksri
S
Sriphong
Lawan
L
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D003278:Contraceptives, Oral, Hormonal / Q000032:analysis*; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D008525:Medroxyprogesterone / Q000032:analysis*; D010084:Oxidation-Reduction; D010226:Parabens; D019999:Pharmaceutical Solutions; D011310:Preservatives, Pharmaceutical; D012015:Reference Standards; D015203:Reproducibility of Results
D003278:Contraceptives, Oral, Hormonal; D010226:Parabens; D019999:Pharmaceutical Solutions; D011310:Preservatives, Pharmaceutical; C015358:methylparaben; D008525:Medroxyprogesterone; C006068:propylparaben