STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ATAZANAVIR AND RITONAVIR IN PHARMACEUTICAL FORMULATION
AbstractA simple, rapid, precise and accurate isocratic reversed-phase stability-indicating HPLC method was developed and validated for the simultaneous determination of Atazanavir (AT) and Ritonavir (RT) in commercial tablets. The method has shown adequate separation for AT, RT from their degradation products. Separation was achieved on a Hypersil BDS-C18, 5 μm, 125 mm × 4.6 mm i.d. column using a mobile phase consisting of buffer (pH3.4) – acetonitrile (50:50, v/v) at a flow rate of 1.5 mL/min and UV detection at 250 nm. The drugs were subjected to oxidation, acid, base hydrolysis, photolysis and heat to apply stress conditions. The linearity of the proposed method was investigated in the range of 7.8–225 μg/mL (r2 = 0.9993) for AT and 2.7-75 μg/mL (r2 = 0.9995) for RT. The limit of detection was 2.4 μg/mL for AT and 0.9 μg/mL for RT. The limit of quantitation was 7.8 μg/mL for AT and 2.7 μg/mL for RT. Degradation products produced as a result of stress studies did not interfere with the detection of AT and RT and the assay can thus be considered stability-indicating
Article Information
26
2659-2666
628KB
1632
English
IJPSR
P. Saritha*, V. Girija Sastry, A. Vijaya Lakshmi and E. Veeraiah
University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam 530 003, Andhra Pradesh, India
pavuluri.saritha@gmail.com
04 March, 2013
08 April, 2013
22 June, 2013
10.13040/IJPSR.0975-8232.4(7).2659-66
01 July, 2013
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