Four Greenness Evaluations of Two Chromatographic Methods: Application to Fluphenazine HCl and Nortriptyline HCl Pharmaceutical Combination in Presence of Their Potential Impurities Perphenazine and Dibenzosuberone

Abstract

Nowadays, when analysts develop a new method, they are taking into consideration the green aspects of the developed method. Two chromatographic methods were developed for the determination of antidepressant pharmaceutical combination nortriptyline hydrochloride and fluphenazine hydrochloride in presence of their potential impurities and the methods were assessed using four tools; eco-scale, analytical greenness profile (AGP), analytical greenness metric approach (AGREE), and green analytical procedure index (GAPI). Method (A) was RP-HPLC, in which the separation was carried out on C18 column (250 × 4.5 mm, 5 µm) by gradient elution using mobile phase consisting of a mixture of water containing 0.1% H3PO4 (pH 2.25) and methanol, at a flow rate of 2 mL/min with DAD detection at 254 nm. Method (B) was TLC, in which the separation was carried out on silica gel TLC F254 plates. The mobile phase used was a mixture of methanol and acetone (9:1, v/v) with UV detection at 245 nm. The proposed methods agreed with ICH guidelines of method validation and were successfully applied for determination of the proposed components in their dosage form and the results were compared statistically to those obtained by the reported RP-HPLC method with no significant difference; which suggests the application of the developed methods for routine quality control analysis of these drugs.