ファーマシューティカ アナリティカ アクタ

概要

The Use of Integrated Analytical Tools for Determination of Cyclopentolate and Naphazoline Hydrochlolrides in Pure and Pharmaceutical Preparations

Eman Y.Z. Frag, Gehad G. Mohamed, F.A. Nour El-Dien and Marwa El-Badry Mohamed

Simple and sensitive spectrophotometric methods were described for the determination of cyclopentolate (CPH) and naphazoline hydrochlorides (NPZ) drugs in pure form and in pharmaceutical preparations based on ion pair and charge transfer complexation reactions, respectively. The first method is based on the reaction of the CPH drug with Mo(V)-thiocyanate in hydrochloric acid medium and dyestuff reagents namely bromophenol blue (BPB), bromocresol green (BCG) and bromocresol purple (BCP). The ion pair complexes formed were quantitatively extracted into dichloroethane, chloroform and methylene chloride in case of Mo(V)-thiocyanate, BPB, and BCP reagents, respectively. The second method is based on charge transfer complex formation between NPZ (electron donor) and TCNQ (π-acceptor reagent). All the experimental variables were optimized. The calibration graphs are rectilinear in the concentration ranges 5.00-250.0, 0.93-56.07, 0.93-56.07 and 1.86-56.07 μg mL -1 for CPH using Mo(V)-thiocyanate, BPB, BCG and BCP reagents, respectively, and 2.00-240.0 μg mL -1 for NPZ using TCNQ reagent. The Sandell sensitivity (S), molar absorptivity, correlation coefficient and regression equations were calculated. The limits of detection (LOD =5.54, 0.51, 0.32, 0.54 and 3.19 using Mo(V)-thiocyanate, BPB, BCG ,BCP and TCNQ reagents, respectively) and limits of quantification (LOQ = 7.55, 1.70, 1.05, 1.80 and 5.60 using Mo(V)-thiocyanate, BPB, BCG , BCP and TCNQ reagents, respectively) are calculated. The law values of standard deviation and relative standard deviation reflect the accuracy and precision of the proposed methods. The two methods can be applied to the analysis of the two drugs in eye drops, with no evidence of interference from excipients. There was no significant difference between each of the two methods and the official one.