Proposal for Determining Sulfate Counter Ion in Amikacin Sulfate Formulations by Fourier-Transform Infrared Derivative Spectroscopy

Ovalles, Fernando; Gallignani, Máximo; Rondon, Rebeca; Ayala, Carlos; Brunetto, Marı́a del Rosario

doi:10.2174/157341213804806115

Cited by 2 publications

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“…For the past two decades, the transmission FTIR spectroscopy has undergone significant application for quantitative purposes, several in the pharmaceutical analysis field 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 . As suggested above, a FTIR spectrum can be used for verifying the identity and purity of API and for detecting any spectral interference originating from the excipients.…”

Section: Introductionmentioning

confidence: 99%

Transmission FTIR derivative spectroscopy for estimation of furosemide in raw material and tablet dosage form

Gallignani

Rondon

Ovalles

et al. 2014

Acta Pharmaceutica Sinica B

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A Fourier transform infrared derivative spectroscopy (FTIR-DS) method has been developed for determining furosemide (FUR) in pharmaceutical solid dosage form. The method involves the extraction of FUR from tablets with N,N-dimethylformamide by sonication and direct measurement in liquid phase mode using a reduced path length cell. In general, the spectra were measured in transmission mode and the equipment was configured to collect a spectrum at 4 cm−1 resolution and a 13 s collection time (10 scans co-added). The spectra were collected between 1400 cm−1 and 450 cm−1. Derivative spectroscopy was used for data processing and quantitative measurement using the peak area of the second order spectrum of the major spectral band found at 1165 cm−1 (SO2 stretching of FUR) with baseline correction. The method fulfilled most validation requirements in the 2 mg/mL and 20 mg/mL range, with a 0.9998 coefficient of determination obtained by simple calibration model, and a general coefficient of variation <2%. The mean recovery for the proposed assay method resulted within the (100±3)% over the 80%–120% range of the target concentration. The results agree with a pharmacopoeial method and, therefore, could be considered interchangeable.

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Section: Introductionmentioning

confidence: 99%

Transmission FTIR derivative spectroscopy for estimation of furosemide in raw material and tablet dosage form

Gallignani

Rondon

Ovalles

et al. 2014

Acta Pharmaceutica Sinica B

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“…Each spectrum was automatically converted to its first-order derivative spectrum. The validation of the analytical method was carried out as it was described by us earlier [19] .…”

Section: Methodsmentioning

confidence: 99%

“…[7] and USP [1] refer to sulfate counter-ion content as a molar ratio between AMK and H 2 SO 4 . The sulfate ion, outside the allowed range, could indicate that AMK is present as a free base or the sulfate ion, in excess, is present as an impurity [19] . Recently, our research group proposed a Fourier-transform infrared (FTIR) method for determining the sulfate counter-ion content in AMK sulfate injections [19] .…”

Section: Introductionmentioning

confidence: 99%

“…FT-mid-IR in conjunction with a continuous flow system (CFS) was extensively used for quantitative estimation of active ingredients in pharmaceutical preparations [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] . The spectrum is a marker for identity and purity of the active pharmaceutical ingredient (API) and also useful to detect impurities coming from the excipients.…”

Section: Introductionmentioning

confidence: 99%

“…A direct reagent-free determination of AMK content in parenteral formulations of AMK sulfate by CFS-FTIR-derivative spectrometry (DS) is proposed keeping in view principles of green analytical chemistry [19] , [29] , [30] , [31] , [32] . The advantage of the present method is to simultaneously quantify AMK base and sulfate counter-ion in AMK sulfate injections with a single spectrum.…”

Section: Introductionmentioning

confidence: 99%

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Reagent-free determination of amikacin content in amikacin sulfate injections by FTIR derivative spectroscopy in a continuous flow system

Ovalles

Gallignani

Brunetto

et al. 2014

Journal of Pharmaceutical Analysis

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The quantitative estimation of amikacin (AMK) in AMK sulfate injection samples is reported using FTIR-derivative spectrometric method in a continuous flow system. Fourier transform of mid-IR spectra were recorded without any sample pretreatment. A good linear calibration (r>0.999, %RSD<2.0) in the range of 7.7–77.0 mg/mL was found. The results showed a good correlation with the manufacturer's and overall they all fell within acceptable limits of most pharmacopoeial monographs on AMK sulfate.

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Proposal for Determining Sulfate Counter Ion in Amikacin Sulfate Formulations by Fourier-Transform Infrared Derivative Spectroscopy

Cited by 2 publications

References 0 publications

Transmission FTIR derivative spectroscopy for estimation of furosemide in raw material and tablet dosage form

Transmission FTIR derivative spectroscopy for estimation of furosemide in raw material and tablet dosage form

Reagent-free determination of amikacin content in amikacin sulfate injections by FTIR derivative spectroscopy in a continuous flow system

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