Saturday , 24 August 2019

Analytical Method Development and Validation for Lamivudine and Zidovudine Combine Pharmaceutical Dosage Forms by RP-HPLC

Dr. Gampa Vijay Kumar*1, Dr. T. Rajesh2, C. Mounika3
1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

2,3KGR 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 Lamivudine and Zidovudine by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Lamivudine and Zidovudine by using Agilent C18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol:Acetonitrile, detection wavelength was 254 nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software- LC-20 Solution. The retention times were found to be 2.335 mins and 3.400 mins. The % purity of Lamivudine and Zidovudine was found to be 99.85% and 100.34% respectively. The system suitability parameters for Lamivudine and Zidovudine such as theoretical plates and tailing factor were found to be 2284, 1.7 and 2886 and 1.7, the resolution was found to be 5.4. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Lamivudine and Zidovudine was found in concentration range of 10µg-50µg and 20µg-100µg 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 0.10 and 0.1, % RSD for intermediate precision was 0.4 and 0.3 respectively. The precision study was precision, robustness and repeatabilty.LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively.

Keywords: Agilent C18, Lamivudine and Zidovudine RP-HPLC

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