药物分析学报

抽象的

Stability Indicating Rp-Hplc Method for Estimation of Doravirine in Tablet Dosage Form

P Sathya Sowmya*, G Somsekhar, Hindustan Abdul Ahad

The estimation of Doravirine was done by RP-HPLC. The assay of Doravirine was performed with tablets and the % assay was found to be 100.50 which show that the method is useful for routine analysis. The linearity of Doravirine was found to be linear with a correlation coefficient of 0.999, which shows that the method is capable of producing good sensitivity. The acceptance criteria of precision is RSD should be not more than 2.0% and the method show precision 0.6 for Doravirine which shows that the method is precise. The acceptance criteria of intermediate precision is RSD should be not more than 2.0% and the method show precision 1.0 for Doravirine which shows that the method is repeatable when performed in different days also. The accuracy limit is the percentage recovery should be in the range of 98.0% - 102.0%. The total recovery was found to be 100.02% for Doravirine. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The acceptance criteria for LOD and LOQ are 3 and 10. The LOD and LOQ for Doravirine was found to be 2.98 and 9.97. The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions. The acceptance criteria for degradation studies are less than 15%. The degradation results are within the limit. Thus the proposed method was found to be accurate, precise, reproducible and specific and can be used for estimation of doravirine in tablet dosage form.