A Stability Indicating Method Development and Validation for The Simultaneous Estimation of Emtricitabine, Tenofovir Alafenamide and Doultegravir in Pharmaceutical Formulation by Ultra Performance Liquid Chromatography

Author(s):  
Kishore Konam ◽  
Somasekhar Reddy Kanala

A Precise, specific, linear, accurate and robust technique used to be developed for the simultaneous estimation of the, Emtricitabine, Tenofovir alafenamide and Doultegravir in pill dosage structure and Validated as per ICH Validation guidelines. Method was once optimised with the useful resource of Acquity BEH C18 125A° (100 × 2.1 mm, 1.7μ) column at a flow rate of 0.6ml/min, Mobile part was as soon as pH 3.8 Buffer, Methanol and Acetonitrile (50:40:10 respectively). The Column Oven temperature used to be maintained at 35°C and working wave dimension used to be selected at 274nm. The retention times of Emtricitabine, Tenofovir Alafenamide and Doultegravir have been determined to be 3.77, 6.34 and 7.67minutes respectively. The % RSD of the Emtricitabine, Tenofovir Alafenamide and Doultegravir had been and located to be 0.27%, 1.24% and 0.11% respectivelyIn Method precision Parameter, % Assay had been determined ninety five to 105.0% and p.c Recovery had been acquired as 98.9%, 100.4% and 100.0% for Emtricitabine, Tenofovir Alafenamide and Doultegravir respectively. Linearity was as soon as acquired as 0.999, 0.999 and 0.999 for Emtricitabine, Tenofovir Alafenamide and Doultegravir respectively. Analytical Range used to be determined from the linearity and accuracy for Emitricitabine used to be 50µg/mL to 150µg/mL, Tenofovir Alafenamide used to be as soon as 6.25µg/mL to 18.75µg/mL and Doultegravir was as soon as 12.5µg/mL to 37.5µg/mL.

2021 ◽  
Vol 11 (6) ◽  
pp. 86-91
Author(s):  
Sachin N. Kapase

For qualitative and quantitative analysis, various analytical techniques are available such as Ultraviolet (UV) Spectrophotometry, High-performance liquid chromatography (HPLC), High-performance thin layer chromatography (HPTLC). As per literature survey, there are some UV, HPLC, Ultra-Performance Liquid Chromatography (UPLC) and HPTLC analytical methods are developed for Montelukast and Doxofylline individually and in a combination with other drugs too, since yet there are no significant stability studies indicating HPLC method reported for Montelukast and Doxofylline combinations. In the current study, the HPLC method is developed and validated for simultaneous quantitative estimations of Montelukast and Doxofylline. These present techniques are more efficient and sensitive as compared to other analytical techniques.


Author(s):  
Poojari Venkatesh ◽  
Umasankar Kulandaivelu ◽  
Gsn Koteswara Rao ◽  
Guntupalli Chakravarthi ◽  
Rajasekhar Reddy Alavala ◽  
...  

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.


Author(s):  
Sana Tabassum ◽  
Dr.M.Sathishkumar ◽  
Dr.A.Mallik ◽  
Dr.N.Jyothi

For the coincident evaluation of Dapagliflozin and Saxagliptin in bulk form; Chromatography was run through Intersil-ODS C18 column (250mm× 4.6mm, 5micron) Mobile phase containing Methanol: Water was pumped through the column in the ratio of 45: 55. The flow rate was 1ml/min. The temperature help was ambient i.e., upto300c. The optimized selected wavelength was 210nm. The retention time of Dapagliflozin and Saxagliptin was found to be 4.707min and6.68 min respectively. The %RSD of Dapagliflozin and Saxagliptin was found to be 0.031 and 0.036 respectively. The values of LOD and LOQ obtained from Dapagliflozin and Saxagliptin was 0.56, 1.69 and 0.57, 1.74 respectively. The retention time was decreased and the run time also decreased, so the method development was simple and economical that can be applied successfully for simultaneous estimation of combination of two anti- diabetic drugs; Dapagliflozin and Saxagliptin. KEY WORDS: Dapagliflozin and Saxagliptin, RP-HPLC.


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