A multivariate quantification of Box‐Behnken design assisted method development and validation of dextromethorphan hydrobromide and desloratadine simultaneously by reverse‐phase HPLC in in‐house syrup formulation

2020 ◽  
Vol 43 (18) ◽  
pp. 3597-3606
Author(s):  
Md. Irshad Alam ◽  
Aquil ur‐Rahim Siddiqui ◽  
Nazia Khanam ◽  
Shaikh Jalil Kamaruddin
Author(s):  
Kuntal Mukherjee ◽  
S. T. Narenderan ◽  
B. Babu ◽  
Survi Mishra ◽  
S. N. Meyyanathan

A simple, sensitive and rapid high performance liquid chromatographic method has been developed for the determination of Propofol. The main focus of the method was to determine Propofol in solution form as well as in marketed formulation. Chromatographic separation was achieved on Inertsil ODS-3V column (250mm x 4.6mm; 5µm) with a mobile phase consisting of methanol: water (85:15), with a flow rate of 1.0ml/min (UV detection at 270nm). Linearity was observed over the concentration range of 10-110µg/ml with a regression equation y=88048x + 44524 and having a regression value (R2) of 0.999. The LOD and LOQ values found to be 10ng and 100ng, respectively. No changes found in ruggedness and robustness studies. The percentage of recovery was found to be 95.25% to 101.81%. Validation studies revealed that the method was specific, accurate, precise, reliable, robust, reproducible and suitable for the quantitative analysis in its pharmaceutical formulations.


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