DEVELOPMENT AND VALIDATION OF RP - UFLC AND UV SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF 10 - (4' - N - [(Β - HYDROXYETHYL) PIPERAZINE] BUTYL) - 1, 3 - DIMETHYL - 10H - ACRIDINONE IN BULK DRUG AS A POTENT DNA INTERCALATOR

The present RP - UFLC and UV methods are relatively simple, rapid , robust and highly precise in the determination of 10 - (4' - N - [(β - Hydroxyethyl) piperazine] butyl) - 1,3 - dimethyl - 10H - acridinone ( HBA ) in bulk drug. The chromatographic separation of the drug was achieved on eclipse plus C 8 column (250×4.6mm i.d. 5μm) using a mobile phase of methanol: water (50:50). The flow rate was 1.0 ml/min and effluents were monitored at 267 nm. The separation was achieved within 3.0 ± 0.2 min. The method showed good linearity in the range of 0 - 10 μg/mL with coefficient of correlation 0.9 906. The intra and inter day RSD ranged within limits. The limit of detection and limit of quantification were 0.140 and 0.424 μg/mL, respectively. UV spectrophotometric determination of HBA in bulk drug was done by using 0.1N HCL as solvent and the absorp tion maxima was found to be 262 nm. A linear response was observed in the range of 0 - 18 μg/mL with a correlation coefficient of 0.999. The method was validated as per ICH guidelines and RSD ranged within limits. These methods can be successfully employed t o quantify HBA in the bulk drug and can be used for routine quality control purposes. Keywords: 10 - (4' - N - [(β - Hydroxyethyl) piperazine] butyl) - 1,3 - dimethyl - 10H - acridinone ( HBA ), Method Validation, RP - UFLC, UV spectrophotometry