Monday , 24 February 2020

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Emtricitabine and Lamivudine in Pharmaceutical Dosage Form

V. Swathi1, 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 Emtricitabine and Lamivudine by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Emtricitabine and Lamivudine  by using ZODIAC –SIL RP C18 4.6×100 mm 3.0µm column, flow rate was 1.0 ml/min, mobile phase ratio was (75:25 v/v) acetonitrile : phosphate buffer (KH2PO4 and K2HPO4)  pH 2.5 (pH was adjusted with orthophosphoric acid), detection wave length was 292 nm. The instrument used was Shimadzu, UV detector, LC solutions. The retention times were found to be 2.746 mins and 3.668 mins. The % purity of Emtricitabine and Lamivudine was found to be 99.95% and 100.63% respectively. The system suitability parameters for Emtricitabine and Lamivudine such as theoretical plates and tailing factor were found to be 3923, 1.43and 3348 and 1.46, the resolution was found to be 8.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Emtricitabine and Lamivudine was found in concentration range of 5µg/mL-25µg/mL and 5µg/mL-25µg/mL 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 1.67 and 1.48, % RSD for intermediate precision was 1.83 and 1.05 respectively. The precision study was precise, robust, and repeatable. LOD value was 0.110 and 3.0, and LOQ value was 0.33 and 9.09 respectively.
Keywords: Emtricitabine, Lamivudine, RP-HPLC, Acetonitrile.

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