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VOL. 3, ISSUE 2 (2018)
Validated RP-HPLC method for estimation of daclatasvir in tablet dosage form
Authors
Santhoshi Priya Dandamudi, Jainendra Kumar Battineni, Vasudha Bakshi, Himabindu Peddapalli, Narender Boggula
Abstract
By considering the current regulatory requirement for an analytical method development, a reversed phase high performance liquid chromatographic method for routine analysis of daclatasvir in capsule dosage form has been developed and validated. A simple, precise, rapid and accurate reverse phase HPLC method was developed. A column of Inertsil ODS-3V C18, 250x4.6mm i.d with 5μ particle size was used. The mobile phase comprises of 0.01M Ammonium acetate with pH adjusted to 3.5 (mobile phase solvent-A) and methanol (mobile phase solvent-B) in the ratio of 20: 80 (v/v).The flow rate was 1.0 ml/min and the effluents were monitored at 284 nm. The retention time was 7.79 min. The detector response was linear in the concentration of 100-300µg/ml. The respective linear regression equation being Y= 28817.742X-14741.2. The limit of detection (LOD) and limit of quantification (LOQ) for were found to be 0.05µg/ml and 0.15µg/ml respectively. The assay was found to be 99.85%.The method was validated by determining its accuracy, precision, system suitability, LOD and LOQ. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of daclatasvir in bulk drug and in its pharmaceutical dosage form.
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Pages:1170-1174
How to cite this article:
Santhoshi Priya Dandamudi, Jainendra Kumar Battineni, Vasudha Bakshi, Himabindu Peddapalli, Narender Boggula "Validated RP-HPLC method for estimation of daclatasvir in tablet dosage form". International Journal of Advanced Research and Development, Vol 3, Issue 2, 2018, Pages 1170-1174
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