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Method Development and Validation for the Simultaneous Estimation of Efavirenz, Lamivudine and Zidovudine through Stability indicating RP-HPLC Method

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Author Affiliations

  • 1 Department of Pharmaceutical Analysis, Grace College of Pharmacy, Kodunthirapully P.O; Palakkad-678004, Kerala, INDIA
  • 2 Grace College of Pharmacy, Kodunthirappully, Palakkad-678004, Kerala, INDIA

Res. J. of Pharmaceutical Sci., Volume 2, Issue (4), Pages 10-18, May,30 (2013)

Abstract

A simple, economic, specific, accurate and precise validated reverse phase liquid chromatographic method has been developed for the estimation of Efavirenz, Lamivudine and Zidovudine in Tablet dosage forms. Here in present method, chromatography was carried out using the instrument Waters HPLC 2695 mode with empower software on a Xterra C18(150mm×4.6mm, 5μ) column with mobile phase of 70 volumes of Water (pH was adjusted to 2.1 with o-phosphoric acid) and 30 volumes of Methanol in isocratic mode. The flow rate was 1ml/min, with injection volume 10μl. Detection was done by using PDA detector at 275nm. The retention time was found to be 1.91, 2.90 and 7.52 min The method was validated in terms of linearity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guidelines. The linearity was found to be in the range of 300-900 μg/ml, 75-225 μg/ml, 150-450 μg/ml for Efavirenz, Lamivudine and Zidovudine with correlation coefficient 0.999. The LOD values were 1.8196, 0.796, 3.166 μg/ml.The LOQ values were 6.065, 2.654 and 10.55 μg/ml respectively. The percentage assay was 99.89, 99.22 and 99.64% for Efavirenz, Lamivudine and Zidovudine. No chromatographic interference from tablet excipients was found. The developed method with good separation could be successfully applied for the determination of Efavirenz, Lamivudine and Zidovudine in its Tablet dosage form.

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