Green analytical quality by design RP-HPLC technique with fluorimetric detection for simultaneous assay of cinnarizine and dompridone.

A green and sensitive factorial design-assisted reversed-phase high-performance liquid chromatography (RP-HPLC) approach with fluorimetric detection has been developed for simultaneous determination of cinnarizine and domperidone in pure materials, commercial single and combined tablets. Both drugs are co-formulated in one dosage form and are commonly used for the effective treatment of motion sickness in the ratio of 4 : 3 for cinnarizine and domperidone, respectively. To achieve the developed method's best performance and reliability, a 23 full factorial design was applied during the optimization of chromatographic conditions. Subsequently, isocratic elution on a C18 column with a mobile phase mixture of methanol and 0.02 M potassium dihydrogen phosphate buffer (85 : 15 v/v, pH 3.0) was performed to achieve the best separation. Moreover, the flow rate of 0.8 ml min-1 was applied during the analysis with fluorescence detection at λex 283 nm/λem 324 nm. The elution process was time effective; it consumed less than 6 min for a complete run as retention time for cinnarizine and domperidone, was 4.5 and 3.5, respectively. Good linearity of the proposed method was achieved within the concentration ranges of 0.2-4.5 and 0.4-5.0 µg ml-1 for domperidone and cinnarizine, respectively. The suggested approach was carefully validated according to the International Council for Harmonization (ICH) guidelines. Moreover, green analytical procedure index (GAPI), national environmental methods index (NEMI), analytical greenness (AGREE) and analytical eco-scale methods were applied to assess and confirm method greenness.

Two green and sensitive spectrofluorimetric approaches for determination of Ambroxol and guaifenesin in their single and combined pharmaceutical formulations.

Ambroxol hydrochloride (AMX) and guaifenesin (GFN) are approved drugs utilized to treat coughs through their potent mucolytic and expectorant properties. Due to their massive, combined administration in many illnesses, there is a persistent need for their concurrent estimation in different pharmaceutical formulations. Two sensitive, environmentally friendly spectrofluorimetric methods were developed. AMX was determined using the first method (I) without interference from GFN. This method depends on the quenching of Erythrosine B (EB) native fluorescence at 552 nm after excitation at 527 nm due to the formation of a non-fluorescent AMX-EB ion-pair complex in Britton-Robinson buffer (BRB) solution pH (3.5). The concentration plot is linear over the 0.25-5.0 µg/mL range, with a mean percent found value of 99.74%. Method (II) depends on measuring the native fluorescence of aqueous GFN solution at two analytical wavelengths, either 300 or 600 nm, after excitation at 274 nm. Relative fluorescence intensity (RFI)-concentration plots are linear over the ranges of 0.02-0.5 and 0.1-2.0 µg/ml, with mean percent found at 99.96% and 99.91% at dual wavelengths, respectively. The proposed methods were successfully applied to assay both drugs in raw materials and different single and combined pharmaceutical formulations. These methods have been thoroughly validated following International Committee on Harmonisation (ICH) guidelines. National Environmental Methods Index, Analytical Eco-Scale, and Green Analytical Procedure Index were used to prove greenness, thereby enhancing their applicability. The proposed techniques provide straightforward, precise, and cost-effective solutions for routine formulation analysis in quality control laboratories.

Eco-friendly, sensitive and inventive first derivative synchronous spectrofluorimetric determination of ciprofloxacin and phenylephrine in their pure form, single and combined eye drops.

A facile, sensitive, accurate and green spectrofluorimetric method was evolved for the assay of ciprofloxacin hydrochloride (CFX) and phenylephrine hydrochloride (PLN) in their co-formulated eye drops with their challengeable ratio of 30:1 for CFX and PLN, respectively. Such drops are clinically used for the treatment of eye bacterial infections. They relieve the symptoms of infection by stopping further growth of the causative microorganisms. The assay principle based on first-order synchronous spectrofluorometric scan using Δ λ = 40 nm in which PLN peak amplitudes were recorded at 283.4 nm, meanwhile CFX was measured at 326.2 nm in the same scans. The calibration curves were linear within the concentration ranges: 0.02-0.5 µg/mL and 0.5-5.0 µg/mL for PLN and CFX, respectively. The method validation was confirmed following the International Conference of Harmonization (ICH) Guidelines. This suggested method was the first one that described simultaneous analysis of PLN and CFX by a spectrofluorimetric technique. In this method, green analytical procedures were implemented to lessen occupational and environmental perils and method greenness was assessed by four assessment tools. GAPI, NEMI, AGREE and Analytical eco-scale were applied to this study and it was deduced from their results that the method had high degree of greenness as it fulfilled all requirements of GAPI, NEMI pictograms and it had high scores of analytical eco scale (97) and AGREE methods (0.82). Subsequently, it was successfully applied to assay both drugs in pure forms, pharmaceutical single and co-formulated eye drops.