RP-HPLC Stability Indicating Method Development and Validation for Simultaneous Determination of Grazoprevir and Elbasvir

2021 ◽  
Author(s):  
Aymen Labidi ◽  
Sami Jebali ◽  
Mehdi Safta ◽  
Latifa Latrous El Atrache
Keyword(s):  
Simultaneous Determination ◽  
Method Development ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation

scholarly journals A Novel UPLC-PDA Stability Indicating Method Development and Validation for the Simultaneous Estimation of Lamivudine and Dolutegravir in Bulk and Its Tablets

2020 ◽  
pp. 52-60
Author(s):  
Poojari Venkatesh ◽  
Umasankar Kulandaivelu ◽  
Gsn Koteswara Rao ◽  
Guntupalli Chakravarthi ◽  
Rajasekhar Reddy Alavala ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Potassium Dihydrogen Orthophosphate

Aim: To develop a stability indicating Rp-UPLC method for the simultaneous determination of Lamivudine, Dolutegravir and their degradants in tablets. Methodology: The chromatographic separation was performed on BEH Shield RP18 (2.1 mmX100 mmX1.7 mm) using a isocratic mobile phase Potassium dihydrogen orthophosphate pH 3 adjusted with orthophosphoric acid: methanol (30:70,% v/v) at a flow rate of 0.5ml/min. Column was maintained at room temperature and eluents are monitored at 258 nm. Results: Retention times of the analytes were found to be at 0.81 and 2.78 mins for Lamivudine and Dolutegravir respectively. The calibration of peak area versus concentration, which was linear from 105 to 315 µg/ml for Lamivudine and 17.5 to 52.5 µg/ml for Dolutegravir, had regression coefficient (r2) greater than 0.999. The method had the requisite accuracy, precision and robustness for simultaneous determination of Lamivudine and Dolutegravir in tablets. Conclusion: The proposed method is simple, economical, accurate, precise and can be successfully employed in routine quality control for the simultaneous analysis of Lamivudine and Dolutegravir in pharmaceutical formulations.

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