Method and Development and Validation for Simultaneous Estimation of Ritonavir and Darunavir in Its API and Pharmaceutical Dosage Form by Using RP HPLC Method

Authors

  • Ayesha Begum Khadernaick Department of pharmaceutical analysis, Shadan Women’s college of pharmacy, Khairatabad, Hyderabad, India
  • Nishat Khatoon Department of pharmaceutical analysis, Shadan Women’s college of pharmacy, Khairatabad, Hyderabad, India

Keywords:

Ritonavir, Darunavir, Validation, stability indicating method, degradation products.

Abstract

A short selective, precise, accurate and sensitive for the estimation of Ritonavir and Darunavir was done by RP-HPLC. The chromatographic separation was clear at the flow rate of 1 ml/min, at UV detection of 244 nm. The assay for ritonavir and darunavir were found to be 100.10 and 100.53 respectively. Which shows that the method is useful for routine analysis. The linearity of Ritonavir and Darunavir was found to be direct with a relationship coefficient of 0.999 and 0.999, which appears that the strategy is competent of creating great affectability the acknowledgment criteria for LOD and LOQ are 3.07 and 10. The LOD and LOQ for Ritonavir
was found to be 3.00 and 10.02 and LOD and LOQ for Darunavir was found to be 3.02 and 10.07. The vigor restrain for versatile stage variety and stream rate variety are well inside the constrain, the % debasement comes about are in limits. Which appears that the strategy is having great framework reasonableness and accuracy beneath given set of conditions. From the recovery and the stability studies, showing acceptable limits, it can be concluded that this can be employed for estimation of ritonavir and darunavir in tablet dosage forms.

Dimensions

Published

2021-05-10