Stability Indicating RP-HPLC Method for Simultaneous Estimation of Atazanavir and Cobicistat in Tablets
M. Venkata Siva Sri Nalini
Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, 522510, Andhra Pradesh, India.
B. Haribabu *
Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, 522510, Andhra Pradesh, India
P. Rama Krishna Veni
Department of Applied Sciences and Humanities, Sasi Institute of Technology and Engineering, Tadepalligudem, 534101, Andhra Pradesh, India.
*Author to whom correspondence should be addressed.
Abstract
Aim: The aim of this study was to develop a stability indicating RP-HPLC method for simultaneous quantitative analysis of atazanavir and cobicistat in tablets.
Place and Duration of Study: At Rainbow Pharma Training Lab, Kukatapally, Hyderabad, India and Department of chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, India in between October 2015 and February 2016.
Methodology: Atazanavir and cobicistat was eluted on the Inertsil C8, 150 mm x 4.6 mm, 5 µm analytical column with a mobile phase consisting of 0.1 M ammonium acetate and methanol (50:50 v/v), pumped at 1.2 mL/min flow rate. The column was maintained at 30°C and 10 μl of the solutions were injected. UV detection was performed at 234 nm. According to ICH guidelines, the method was validated.
Results: Under the optimized chromatographic conditions the retention times of atazanavir and cobicistat were 2.559 min and 3.576 min, respectively. Linearity was observed in the concentration range of 45-135 μg/mL for atazanavir and 22.5-67.5 μg/mL for cobicistat. The percent recovery and percent relative standard deviation for both the drugs were in the range of 99.311-100.342% and 0.290-0.401%, respectively. The results of forced degradation studies demonstrated the stability-indicating power of the method.
Conclusion: The proposed method was found to be appropriate for the quality control of atazanavir and cobicistat hydrochloride simultaneously in a bulk drug as well as in a pharmaceutical dosage forms.
Keywords: Antiretroviral drugs, HPLC, forced degradation, analysis, tablets