HPLC method for the development and validation of busulfan in pharmaceutical formulation
1 Department of Chemistry, AUEC (A), Visakhapatnam, India.
2 Department of Chemistry, MVR College, Visakhapatnam, Andhra Pradesh 530045, India.
GSC Advanced Research and Reviews, 2021, 06(03), 136-142.
Article DOI: 10.30574/gscarr.2021.6.3.0051
Publication history:
Received on 10 February 2021; revised on 13 March 2021; accepted on 15 March 2021
Abstract:
A validated HPLC method was developed for the determination of Busulfan (BUS) in pharmaceutical formulation.It is a new simple, accurate, precise and reproducible HPLC method has been developed for the estimation of Busulfan (1,4-butanediol dimethanesulfonate) in its inject able dosage.The method developed in High Performance Liquid Chromatographic method using suitable column (YMC Pack ODS-A (150 x 4.6) mm, 3µm). All the components of the system are controlled using SCL-10Avp System Controller. Data acquisition was done using LC Solutions software.The method was validated as per the ICH guidelines. Thus, the proposed HPLC method can be successfully applied for the routine quality control analysis of formulations. The method developed is simple and is better than the methods reported in the literature and the method is capable to give a good detector response, the recovery calculated was within the range of 98% to 102% of the specification limits.
Keywords:
Busulfan (BUS); HPLC, ICH Q2 (R1); Recovery
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