International Journal of Pharmaceutical Investigation, 2019, 9, 3, 135-140.
Published: November 2019
Type: Original Article
Kiran Kumar Buralla
Department of Pharmacy, Annamalai University, Annamalainagar, Chidambaram, Tamil Nadu, INDIA
Department of Pharmacy, Centre for Cell Biology and Drug Discovery, Annamalai University, Annamalainagar, Chidambaram, Tamil Nadu, INDIA
Objectives: This paper describes the development of an accurate, precise, robust, sensitive, economical and rapid isocratic RP-HPLC technique complying quality by design and validate according to ICH guidelines. The simultaneous estimation of the Pazopanib with Dasatinib as internal standard in bulk and pharmaceutical dosage forms with the help of chemo metrics, multicriteria decision-making approach. The main objective was to identify the robust chromatographic conditions where an adequate separation of the components with quality peaks, within acceptable run time can be achieved. Target Analytical Profile (TAP) was defined and systematic risk analysis was carried out to identify Critical Method Attributes (CMA) having an impact on Critical Quality Attributes (CQA). % Acetonitrile (ACN), KH2PO4, pH and Flow rate was identified as CMA. Methods: The effective chromatographic separation was achieved by utilizing Phenomenex Enable C18 column and mobile phase consisted of ACN and Phosphate buffer (60:40 %v/v, pH 5) adjusted with orthophosphoric acid and the flow rate of 1.2 ml/min. the elution was monitored at 290nm using a PDA-UV detector. Results: The developed method resulted in eluting the drug at 2.190 min, respectively. The regression coefficients were observed to be 0.998 for all models. The LOD was about 10.74 nano-gram/ml and LOQ were about 31.74 nano-gram/ml. The relative standard deviation was observed to be 0.5079%. Conclusion: The results of the study demonstrated that the suggested RP-HPLC method is rapid, simple, accurate and precise. The method was validated by determining its accuracy, precision and system stability.
Keywords: RP-HPLC, Tyrosine kinase inhibitors, Pazopanib, Dasatinib, Quality by Design.