Zero and second‐derivative synchronous fluorescence spectroscopy for the quantification of two non‐classical β‐lactams in pharmaceutical vials: Application to stability studies

Abstract

The formation of metal chelates with various ligands may lead to the production of fluorescent chelates or enhance the fluorescence of the chelating agent. This paper describes two sensitive, selective and computer-solved methods, namely, zero order (SF) and second-derivative synchronous spectrofluorimetry (SDSFS) for nano-quantitation of two carbapenems; meropenem (MP) and ertapenem (EP). The methods are based on the chelation of MP with Tb and EP with Zr in buffered organic medium at pH 4.0 to produce fluorescent chelates. In the zero order method, the relative synchronous fluorescence intensity is measured at 327.0 nm at Δλ = 70.0 and 100.0 nm for MP and EP, respectively. The second method utilizes a second-derivative technique to enhance the method selectivity and emphasize a stability-indicating approach. The peak amplitudes ( D) of the second-derivative synchronous spectra were estimated to be 333.06 and 330.06 nm for MP and EP, respectively. The proposed synchronous spectrofluorimetric methods were validated according to the International Conference on Harmonization (ICH) guidelines and applied successfully for the analysis of MP and EP in pure forms, pharmaceutical vials and in synthetic mixtures with different degradants of both drugs. Under optimum conditions, the mole-ratio method was applied and the co-ordination ratios of MP-Tb and EP-Zr chelates were found to be 1:1 and 1:3. The formation constants for the chelation complexes were evaluated using the Benesi-Hildebrand's equation; the free energy change (ΔG) was also calculated. The results indicated that EP-Zr was more stable than the MP-Tb chelate. Moreover, the developed methods were found to be selective and inexpensive for quantitative determination of both drugs in quality control laboratories at nano-levels.

Challenge Approach of an Inexpensive Electrochemical Sensor for Rapid Selective Determination of two Non‐classical β‐Lactams in Presence of Different Degradants and Interference Substances

“…First major degradant exhibited the persistence of the characteristic β ‐lactam carbonyl group with the formation of sulfone group (O=S=O) and the second one was the same as the hydrolytic degradant. Scheme (a & b) is the suggested pathways for the hydrolytic and oxidative degradation of the studied drugs .…”

“…Then, hydrolytic degradants were neutralized with NaOH or HCl (0.5 M, each). All prepared degradants were evaporated on a thermostatic water‐bath (60 °C) to dryness . The collected degradants’ residues were dissolved in 25.0‐mL water, separately, to obtain a final concentration of 1.0×10 −3 M.…”

A bio-analytically validated HPLC-UV method for simultaneous determination of doripenem and ertapenem in pharmaceutical dosage forms and human plasma: a dual carbapenem regimen for treatment of drug-resistant strain of Klebsiella pneumoniae

“…Based on our survey, many analytical methods have been reported for analysis of DOR and ERTA such as spectrophotometric, 8–11 spectrofluorimetric, 12–14 HPLC, 15–18 HPTLC 19 and electrochemical 20 methods.…”

“…[2][3][4][5][6] As previously reported, utilization of the recommended carbapenem mixture treatment against KPC strains led to an enhancement in the antibacterial activity in vitro and in vivo. [2][3][4][5][6][7] Based on our survey, many analytical methods have been reported for analysis of DOR and ERTA such as spectrophotometric, [8][9][10][11] spectrouorimetric, [12][13][14] HPLC, [15][16][17][18] HPTLC 19 and electrochemical 20 methods.…”

“…The presented work showed higher sensitivity when compared with previous reported methods. 12,22 Moreover, the presented method considered selective when compared with other spectrometric [8][9][10][11][12][13] methods. In addition, the proposed HPLC-UV method is rapid and don't consume long analysis time when compared with other methods.…”