Validated simultaneous determination of antipyrine and benzocaine HCl in the presence of benzocaine HCl degradation product

2014 ◽  
Vol 6 (15) ◽  
pp. 6044-6050 ◽  
Author(s):  
Hanan A. Merey ◽  
Hala E. Zaazaa

Two validated, sensitive and highly selective stability-indicating methods were adopted for the simultaneous quantitative determination of antipyrine (ANT) and benzocaine HCl (BEN) in the presence of the degradation product of benzocaine HCl [p-aminobenzoic acid (PABA)].

Author(s):  
Hany W. Darwish ◽  
Nesma A. Ali ◽  
Ibrahim A. Naguib ◽  
Mohamed R. El Ghobashy ◽  
Abdullah M. Al-Hossaini ◽  
...  

Author(s):  
Murlidhar V. Zope ◽  
Rahul M. Patel ◽  
Ashwinikumari Patel ◽  
Samir G. Patel

Objective: The objective of the current study was to develop and validate a simple, robust, precise and accurate RP-HPLC (reverse phase-high performance liquid chromatography) method for the quantitative determination of potential degradation products of Difluprednate (DIFL) in the ophthalmic emulsion.Methods: Chromatographic separation was achieved on the YMC pack ODS-AQ (150× 4.6) mm, 3μm column with a mobile phase containing a gradient mixture of mobile phase A (0.02M Ammonium formate buffer pH 4.5 adjusted with formic acid) and Acetonitrile as mobile phase B, at flow rate of 1.5 ml/min and with UV detection at 240 nm.Results: The peak retention time of DIFL was found at about 17.2 min, the RRT of degradation product-1 (DP-1), degradation product-2 (DP-2), and degradation product-3 (DP-3), were found to be about 0.49, 0.65 and 0.79 respectively (calculated with respect to Difluprednate). Stress testing was performed in accordance with an ICH (international council for harmonisation) guideline Q1A (R2) [1]. The method was validated as per ICH guideline Q2 (R1)[2]. The calibration curve was found to be linear in the concentration range of 0.1 to 0.75 µg/ml for Difluprednate, DP-1, DP-2 and DP-3. The LOD (Limit of detection) was found to be 0.1µg/ml and LOQ (Limit of quantification) of 0.15µg/ml for Difluprednate, DP-1, DP-2 and DP-3 respectively. The recovery from LOQ to 150% was within 90-110%. The forced degradation data confirms the stability indicating the nature of the method.Conclusion: A simple, robust, precise and accurate RP-HPLC method for the quantitative determination of potential degradation products of Difluprednate in the ophthalmic emulsion was developed and validated. 


2007 ◽  
Vol 847 (2) ◽  
pp. 224-230 ◽  
Author(s):  
Mugunthu R. Dhananjeyan ◽  
Crystal Bykowski ◽  
Jill A. Trendel ◽  
Jeffrey G. Sarver ◽  
Howard Ando ◽  
...  

RSC Advances ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 3834-3842
Author(s):  
Khalid A. M. Attia ◽  
Ahmad A. Mohamad ◽  
Mohamed S. Emara ◽  
Ahmed M. Abdel-Raoof ◽  
Mohamed A. Hasan ◽  
...  

In this work, the quantitative determination of an erectile dysfunctional drug avanafil in the presence of its acid-induced degradation product was achieved via the application of a pre-optimized novel spectrofluorimetric method.


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