SOLID STATE CHARACTERIZATION AND QUANTIFICATION OF ABACAVIR SULPHATE, LAMIVUDINE AND ZIDOVUDINE AND ITS TABLET FORMULATION BY X-RAY POWDER DIFFRACTION METHOD
Objective: To determine simultaneously the content of crystallinity of Abacavir sulphate (ABC), Lamivudine (LMD) and Zidovudine (ZVD) using X-ray Powder Diffraction (XRPD) technique and to validate the developed analytical methods and to statistically perform correlations by ANOVA technique.
Methods: Characteristic non-interfering peaks of ABC, LMD and ZVD were identified by using X-Ray Powder Diffraction method for assessment of the content of crystallinity.
Results: A working range 70 % to 130 % was taken for the establishment of linearity of the ABC, LMD and ZVD in the formulation and the coefficient of regression of ABC was 0.999, LMD was 0.998 and ZVD was 0.998. The F value by ANOVA was found to be within limits and satisfactory.
Conclusion: The developed method was adapted to the samples exposed to 40 Â°C/75 % RH, accelerated stability conditions and hence proved that it can be used for monitoring real-time samples.
Keywords: Abacavir sulphate, Lamivudine, Zidovudine, Crystallinity, XRPD, Validation
2. Yuen GJ, Weller S, Pakes GE. A review of the pharmacokinetics of abacavir. Clin Pharmacokinet 2008;47:351-71.
3. Fox Z, Dragsted UB, Gerstoft J. A randomized trial to evaluate continuation versus discontinuation of lamivudine in individuals failing a lamivudine-containing regimen: the COLATE trial. Antiviral Ther 2006;11:761-70.
4. Schrive I, Plasse JC. Quantification of zidovudine and one of its metabolites in plasma and urine by solid-phase extraction and high-performance liquid chromatography. J Chromatogr B: Biomed Sci Appl 1994;657:233-7.
5. Jozwiakowski MJ, Nguye NAT, Sisco JM, Spancake CW. Solubility behavior of lamivudine crystal forms in recrystallization solvents. J Pharm Sci 1996;85:193-9.
6. Harris RK, Yeung RR, Lamont RB, Lancaster RW, Lynn SM, Staniforth SE. â€˜Polymorphismâ€™ in a novel anti-viral agent: lamivudine. J Chem Soc Perkin Trans 1997;2:2653-4.
7. Singh GP, Srivastava D, Saini MB, Upadhyay PR. A novel crystalline form of lamivudine. WO; 2007.
8. Renu Chadha, Poonam Arora, Swati Bhandari. Polymorphic forms of lamivudine: characterization, estimation of transition temperature, and stability studies by thermodynamic and spectroscopic studies. ISRN Thermodyn 2012;2:62-70.
9. Savaser A, Goraler S, Tasoz A, Uslu B, Lingeman H, Ozkan SA. Simultaneous RP-LC determination of abacavir sulphate, lamivudine and zidovudine in pharmaceutical tablets, human serum and in drug dissolution studies. Chromatographia 2007;65:259-66.