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VALIDATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR DETERMINATION OF STAVUDINE IN HUMAN PLASMA

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Abstract (2. Language): 
A simple, accurate, precise and sensitive HPLC method with UV detection was developed and validated to estimate Stavudine in human plasma. It was extracted from human plasma using methanol, by using protein precipitation method. It was chromatographed on a Phenomenex Luna Ci8 column using 50LIL injection volume and UV detector. An isocratic mobile phase consisting of a mixture of ortho phosphoric acid buffer (pH 3.8) and Methanol (1:9) was used in the analysis. The retention time (Rt) of the drug was found 6.5 mins. The method was validated over the range of 0.025Lig/mL to 1.750 Lig/ımL. The intra and inter-day precision (%RSD.) values of Stavudine for various concentrations ranged from 1.369% to 4.166%. The maximum recovery was achieved at medium and high quality control samples and was 98.40%. The described method can be readily utilized for routine quality control and evaluation of clinical data of Stavudine in human plasma.
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397-407

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