DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC ASSAY METHOD FOR DETERMINATION OF PHENOBARBITONE IN BULK DRUG AND TABLET FORMULATIONAbstract
The objective of the current study was to develop simple, precise and accurate stability indicating by isocratic RP-HPLC assay method and validated for determination of Phenobarbitone in solid pharmaceutical dosage forms. Isocratic RP-HPLC separation was achieved on a analytical C18 R column (250 mm × 4.6 mm i.d., 5 μm particle size) using mobile phase of Acetonitrile: Methanol (65:35, v/v) at a UV detector. The drug was subjected to acid degradation, alkaline degradation, oxidation, photolysis and heat to apply stress condition. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 10-60 μg/ml with a correlation coefficient 0.999. The method was also found to be robust as indicated by the % RSD values which are less than 2%. The stress degradation studies showed that Phenobarbitone undergoes degradation in acid, base, oxidation, dry heat (4.80%, 1.52%, 2.16%, and 1.81% respectively). Degradation products produced as a result of stress studies did not interfere with detection Phenobarbitone and the assay can thus be considered stability indicating.
P.R. Mhatre*, S.H. Gatkal, V.V. Chopade and P.D. Choudhari
Department of Quality Assurance Techniques, Modern College of Pharmacy Nigdi, Pune-411044, Maharashtra, India
12 January, 2013
04 March, 2013
24 April, 2013
01 May, 2013