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Title DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND ZIDOVUDINE IN API AND PHARMACEUTICAL DOSAGE FORM USING RP-HPLC
Authors *J. Priyanka and P. Anil Kumar
Description A rapid, sensitive and specific RP-HPLC [1-5] method involving UV detection was developed and validated for determination and quantification of Lamivudine and Zidovudine.&nbsp; Chromatography&nbsp;&nbsp; was&nbsp; carried out on Thermo Hypersil BDS, C18,(150 x 4..6 mm,5&#61549;) column&nbsp;&nbsp; using&nbsp; filtered&nbsp; and&nbsp; degassed&nbsp;&nbsp; mixture of&nbsp; Buffer : Methanol : Acetonitrile (70:5:25) as mobile&nbsp; phase&nbsp; at&nbsp; a&nbsp; flow&nbsp; rate&nbsp; of&nbsp; 0.8ml/min and effluent was monitored at 267nm. The method was&nbsp; validated&nbsp; in&nbsp; terms&nbsp; of&nbsp; linearity,&nbsp; precision,&nbsp; accuracy,&nbsp; robustness&nbsp; and&nbsp; specificity,&nbsp; limit of&nbsp; quantification and limit of&nbsp; detection.&nbsp; The&nbsp; assay&nbsp; was&nbsp; linear&nbsp; over&nbsp; the&nbsp; concentration&nbsp; range&nbsp; of&nbsp;&nbsp; Lamivudine&nbsp; and&nbsp; Zidovudine&nbsp;&nbsp; was&nbsp;&nbsp; 37.5&micro;g - 225&micro;g/ml&nbsp; and&nbsp; 75&micro;g&nbsp; to 450&micro;g/ml&nbsp; respectively.&nbsp; Accuracy&nbsp; of&nbsp; the&nbsp; method was determined through recovery studies by adding&nbsp; known&nbsp; quantities&nbsp; of standard&nbsp; drug&nbsp; to&nbsp; the&nbsp; pre&nbsp; analyzed&nbsp; test solution&nbsp; and&nbsp; was&nbsp; found&nbsp; to be 99.50%-100.7% and 99.9%-100.7%&nbsp;&nbsp; within&nbsp;&nbsp;&nbsp; precision&nbsp;&nbsp;&nbsp; RSD&nbsp; of&nbsp; 1.30&nbsp;&nbsp; and&nbsp;&nbsp; 0.61&nbsp; for&nbsp;&nbsp; Lamivudine and Zidovudine&nbsp; respectively.&nbsp; The method does require only 10 minutes as run time for analysis which prove the adoptability of the method for the routine quality control of the drug. <br />

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