Abstract
A stability-indicating reversed phase ultra-fast liquid chromatographic method was developed to determine asenapine maleate (ASN) in pharmaceutical dosage form. A two level factorial design was adopted to improve intermediate precision considering analysts, instruments and number of days as the variables. Chromatographic separation was achieved on Enable-C18G (250× 4.6 mm i.d., 5 μm) column using acetonitrile: 0.01M TBAHS (40:60 v/v) as mobile phase at flow rate of 1.0 ml/min and with PDA detection at 229 nm. Calibration curve was linear in the range of 1.0-200 μg/ml. Values of accuracy were within the acceptance limit with mean percent recoveries between 101.2-101.5%. The percent RSD values were within the acceptance limit for repeatability and intermediate precision. Limit of detection and limit of quantitation were found to be 0.25 and 0.5 μg/ml, respectively. Besides, applicability of analytical method showed high specificity for ASN and its degradation products formed during forced degradation studies. The developed UFLC method was found to be specific, selective, accurate, precise and robust for determination of ASN in bulk and pharmaceutical dosage form.
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