Monday , 24 February 2020

RP-HPLC Method Development and Validation for Simultaneous Estimation of Dasatinib and Lenvatinib in Its active Pharmaceutical Ingredient and Pharmaceutical Dosage Forms

B. Yamuna Rani1, Dr. D. Naresh2, Dr. Gampa Vijay Kumar3*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
3Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A  B  S  T  R A C T
A new method was established for simultaneous estimation of a Dasatinib and Lenvatinib by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Dasatinib and Lenvatinib by using Hypersil ODS C18 5µm (4.6*250mm) column, flow rate was 0.8 ml/min, mobile phase ratio was (30:75 v/v) acetonitrile: phosphate buffer (KH2PO4 and K2HPO4)pH 3.0 (pH was adjusted with orthophosphoric acid), detection wavelength was 255 nm. The instrument used was Shimadzu, UV detector, LC solutions. The retention times were found to be 2.669 mins & 2.915mins. The % purity of Dasatinib and Lenvatinib was found to be 99.95% and 100.24%respectively. The system suitability parameters for Dasatinib and Lenvatinib such as theoretical plates and tailing factor were found to be 4668.7, 1.2 and 6090.3 and 1.3. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Dasatinib and Lenvatinib was found in concentration range of 100-500 mg/mland 1-5mg/mland correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.84%and 100.51%, %RSD for precision was 0.2 and 0.6, % RSD for intermediate precision was 0.2 and 0.1 respectively. The precision study was precise, robust, and repeatable. LOD value was 2.9 and 2.3, and LOQ value was 10.03 and 10.1 respectively.
Key words: Dasatinib, Lenvatinib, RP-HPLC, Methanol, validation.

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