scholarly journals Development and Validation of Chromatographic Methods for Simultaneous Determination of Ibuprofen and Famotidine in Presence of Related Substances in Pharmaceutical Formulations

2015 ◽  
Vol 62 (1) ◽  
Author(s):  
Eman S. Elzanfaly ◽  
Hala E. Zaazaa ◽  
Aya T. Soudi ◽  
Maissa Y. Salem
Keyword(s):  
Simultaneous Determination ◽  
Pharmaceutical Formulations ◽  
Chromatographic Methods ◽  
Related Substances ◽  
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.

scholarly journals Stability-Indicating Simultaneous Determination of Paracetamol and Three of Its Related Substances Using a Direct GC/MS Method

2009 ◽  
Vol 92 (6) ◽  
pp. 1622-1630 ◽  
Author(s):  
Tarek Belal ◽  
Tamer Awad ◽  
C Randall Clark
Keyword(s):  
Simultaneous Determination ◽  
Pharmaceutical Formulations ◽  
Fragmentation Pathways ◽  
Stability Indicating ◽  
Related Substances ◽  
Fragment Ions ◽  
Peak Areas ◽  
Impact Mode ◽  
Detection And Quantification

Abstract A simple, direct, and selective stability-indicating GC/MS procedure was developed for the simultaneous determination of paracetamol (PR) and three of its related substances: 4-aminophenol (4-AP), acetanilide (AD), and 4-chloroacetanilide (4-CA). The method involved resolution of the underivatized compounds using a 100 dimethylpolysiloxane (Rtx-1) column, and MS detection was carried out in the electron-impact mode. The four compounds were completely resolved in less than 11 min. The fragmentation pathways for the four compounds were described, and the structures of the major fragment ions peaks were proposed. Quantification of the analytes was based on measuring their peak areas. The reliability and analytical performance of the proposed method including linearity, range, precision, accuracy, and detection and quantification limits were statistically validated. Calibration curves were linear over the ranges 75500, 25350, 25350, and 25350 g/mL for PR, 4-AP, AD, and 4-CA, respectively. The proposed method was successfully applied for the determination of PR and its related substances in laboratory-prepared mixtures of different proportions. Also, it was applied for the assay of PR in several commercially available pharmaceutical formulations with recoveries of 98.95100.76.

Development and validation of stability indicating chromatographic methods for simultaneous determination of citicoline and piracetam

2020 ◽  
Vol 43 (15) ◽  
pp. 2981-2988
Author(s):  
Maha M. Abdelrahman ◽  
Amal B. Ahmed ◽  
Mahmoud A. Omar ◽  
Sayed M. Derayea ◽  
Nada S. Abdelwahab
Keyword(s):  
Simultaneous Determination ◽  
Stability Indicating ◽  
Chromatographic Methods ◽  
Development And Validation
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