RP-HPLC METHOD DEVELOPMENT FOR THE ASSAY AND DEGRADATION STUDY OF COBICISTAT AND ATAZANAVIR SULPHATE IN BULK AND COMBINED DOSAGE FORM
B. Valli Purnima, M. Santha Kumari, G. Ramu, T. Vijaya Bhaskara Reddy, D. Ramachandran*
ABSTRACT
Objective: A reversed phase high performance liquid chromatography (RP-HPLC) method was developed and
validated for the assay of Atazanavir sulphate (ATV) and Cobicistat (COBI) simultaneously in bulk and
pharmaceutical formulations. The method was intentionally developed for the study of stability of the drug
samples under different degradation conditions. Experimental: Waters HPLC system equipped with auto sampler,
Inertsil ODS C18 (4.6 x 150mm, 5.0m) column and photo diode array (PDA) or ultra violet (UV) detector were
adopted in method development. Exactly 20 μl of working standard (15 μg/ml of ATV and 30 μg/ml of COBI) is
introduced into column at ambient temperature, mobile phase of a mixture of 0.1% orthophosphoric acid buffer of
pH 5.5, methanol in the ratio 30:70 v/v was allowed to flow through the column at a flow rate of 1.0 ml/min for a
run time of 8.0 minutes, and the components were detected at a wavelength of 242 nm. The chromatographic data
was obtained by using Empower -2 software. Results: System suitable parameters such as number of theoretical
plates, peak area, tailing factor for COBI and ATV were found to be 2529.34, 44562, 1.9 and 3588.27, 217752.7,
1.20 respectively. The retention time and resolution between the two peaks were found to be 1.994 and 3.325min
and 4.58 respectively. Assay of COBI and ATV was found to be 100.35 and 100.48 % respectively. The stability
of the drug sample under different degradation conditions was determined and found to be within the range of
86.46 to94.72 and 83.97 to 92.82 for COBI and ATV respectively. Conclusions: The developed method was
found to be simple, rapid and applied for the analysis of drug samples, therefore the proposed method is
recommended for the analysis of COBI and ATV in pure and tablet dosage forms in any quality control
laboratories.
Keywords: Atazanavir sulphate, Cobicistat, Validation, Stability, Assay.
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