RP-HPLC Method Development and Validation for Determination of Didanosine in Pharmaceutical Dosage Forms

  • Sachin Gholve
  • Sharddha Gangapure
  • Mahesh Birajdar
  • Imran Mujewar
  • Omprakash G Bhusnure

Abstract

To develop a simple, cheap, accurate, and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for estimation of Didanosine in pharmaceutical dosage forms. The separation was conducted by using mobile phase consisting of methanol: water in the ratio (30:70). The wavelength was found at 246nm. Agilent 1220 Infinity LC with ezchrome software is used for chromatographic determination. The separation was conducted by using Zebra Eclipse XDB-C-18 (4.6×250×5µm) at the flow rate of 1.0 ml/min using variable wavelength detector. The developed method resulted in didanosine eluting at 4.650 min. The method was found to be linear over the concentration range 2-12µg/ml with coefficient regression R2-0.997. Mean recovery was found to be in the range of 99.99%, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 5 mg/ml and 16 mg/ml respectively. A cheap, accurate, precise, linear and rapid RP-HPLC method was developed and validated for the quantitative estimation of Didanosine as per ICH guidelines.


Keywords:-RP-HPLC, Didanosine, Method Validation

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Gholve S, Gangapure S, Birajdar M, Mujewar I, Bhusnure OG. RP-HPLC Method Development and Validation for Determination of Didanosine in Pharmaceutical Dosage Forms. JDDT [Internet]. 15Aug.2019 [cited 3Jun.2020];9(4-s):343-7. Available from: http://jddtonline.info/index.php/jddt/article/view/3328

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