Monday , 18 March 2019

Analytical Method Development and Validation for the Simultaneous Estimation of Darunavir and Cobicistat by RP- HPLC Method

Dr. K. Nageswara Rao1*, Raghava Doonaboyina2, T. Naga Sirisha Devi3
1Professor and Head, Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.
2Associate Professor and Head, Department of Pharmaceutical Chemistry, K.G.R.L College of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.
3K.G.R.L College of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.

A B S T R A C T
A new method was established for simultaneous estimation of Cobicistat and Darunavir by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Cobicistat and Darunavir by using XterraC185µm (4.6*250mm) column, flow rate was1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoricacid), detection wave length was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-softwareversion-2.Theanalyticalmethodwas validated according to ICH guidelines (ICH, Q2(R1)). The linearity study for Cobicistat and Darunavir was found  in  concentration  range   of  1μg-5μg  and  100μg-500μg   and correlation coefficient(r2)was found to be 0.999and 0.999,%mean recovery was found to be 100% and 100.5%, %RSD for repeatability was.0.2 and 0.4, %RSD for intermediate precision was 0.5and 0.1 respectively.
Keywords: Cobicistat Darunavir, RP-HPLC, Phosphate buffer, ACN

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