Analytical Method Development and Vaidation for Ombitasvir and Paritaprevir in Combined Dosage Form by RP-HPLC

K.Nithiyananthan^1*, K.V.S.Prasadarao^2
1Research Scholar,  Acharya Nagarjuna University, Guntur, Andhra Pradesh 522510.
²Principal, Rahul Institute  of Pharmaceutical Sciences And Research, Chirala, Andhra Pradesh 523157

A B S T R A C T
Ombitasvir and Paritaprevir by using Thermosil C18 column (4.0×125mm) 5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: Sodium acetate buffer pH 3 (pH was adjusted with orthophosphoric acid), detection wavelength was 252nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2690, photodiode array detector 996, Empower-software version-2. The retention times were found to be 2.566 mins and 3.417 mins. The % purity of Ombitasvir and Paritaprevir was found to be 101.27% and 99.97% respectively. The system suitability parameters for Ombitasvir and Paritaprevir such as theoretical plates and tailing factors were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study Ombitasvir and Paritaprevir was found in concentration range of 5µg-25µg and 50µg-250µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.86 and 0.82, % RSD for intermediate precision was 0.44 and 0.19 respectively. The precision study was precise, robust, and repeatable.LOD value was 3.17 and 5.68, and LOQ value was 0.0172 and 0.2125 respectively.
Keywords: Ombitasvir  and Paritaprevir, WATERS HPLC, ICH guidelines etc.