Determination of As, Cd, Hg and Pb in continuous use drugs and excipients by plasma-based techniques in compliance with the United States Pharmacopeia requirements

Silva, Caroline Santos da; Pinheiro, Fernanda C.; Amaral, Clarice D.B.; Nóbrega, Joaquim A.

doi:10.1016/j.sab.2017.10.004

Cited by 13 publications

(7 citation statements)

References 10 publications

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“…All analytes were below their respective LOQ values for all samples analyzed. This pattern was also observed in previous studies with commercial drug samples in solid dosage form 26,27,31,[33][34][35] . Consequently, all samples are within the limits recommended by the USP Chapter insert, i.e., lower than 10 g day -1 for tablets drugs.…”

Section: Accuracysupporting

confidence: 87%

“…Taking into account the low target limits for elements from class 1 4,6 , Table 5 summarizes analytical methodology previously reported for Cd, Hg and Pb determination in pharmaceutical samples using ICP OES. Considering MDD of 10 g day -1 , the LOQ values obtained for Cd 26,31,32 , Hg 26 and Pb 26,[31][32][33] were higher than 0.3J (i.e., LOQ established by USP). As it can be noted, none of the aforementioned analytical methods meet the USP requirements for these three analytes at the same time.…”

Section: Limits Of Detection and Quantificationmentioning

confidence: 84%

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Dispersive liquid–liquid microextraction of Cd, Hg and Pb from medicines prior to ICP OES determination according to the United States Pharmacopeia

et al. 2021

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Section: Accuracysupporting

confidence: 87%

Section: Limits Of Detection and Quantificationmentioning

confidence: 84%

Dispersive liquid–liquid microextraction of Cd, Hg and Pb from medicines prior to ICP OES determination according to the United States Pharmacopeia

et al. 2021

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“…For analysis of omeprazole drug samples, two microwave-assisted sample preparation procedures were performed: 1) microwave-assisted sample preparation adopted as reference procedure using inverse aqua regia [20,21,22,23,24] and 2) microwave-assisted sample digestion using 2.0 mol L À1 HNO 3 , as previously proposed by Pinheiro et al [18].…”

Section: Determination Of Elemental Impurities In Omeprazole Drug Samplesmentioning

confidence: 99%

Elemental impurities analysis in name-brand and generic omeprazole drug samples

Pinheiro

Barros

Nóbrega

2020

Heliyon

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Elemental impurities in drug samples can generate unwanted pharmacological-toxicological effects, therefore they must be carefully monitored. In order to update the elemental analysis of pharmaceutical products, new regulations for elemental impurities were published by the United States Pharmacopoeia (USP). This work presents elemental analysis of 23 analytes in omeprazole drug samples from seven different commercial brands considering reference, similar and generic medicines using inductively coupled plasma mass spectrometry (ICP-MS). Microwave-assisted digestion using 2.0 mol L À1 HNO 3 (partial digestion) was applied successfully for omeprazole drugs. Most analytes were below the respective limits of quantification, except for As, Ba, Cd, Co, Cu, Cr, Li, Mo, Ni, Pb, Sb and V. However, the determined concentrations for these analytes were lower than the limits proposed by the USP Chapter 232 and similar for all products, inferring that for the seven analyzed samples there is no difference among reference, similar and generic drugs considering contaminants contents. Discussions considering potential risks of elemental contamination taking into account diverse brands were presented.

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“…They digested ibuprofen tablets, suspension, and gel formulation using a four-step microwave digested procedure, and elements like arsenic, cadmium, mercury, lead, vanadium, cobalt, and nickel were analyzed by the ICP-OES technique. A novel ICP-MS method for elements like arsenic, cadmium, mercury, and lead in a few drugs and excipients was developed by Caroline Santos da Silva et al 25 The aim of this research work was to develop and validate a simple, fast, reliable, inductively coupled plasma mass spectrometric method for the estimation of elemental impurities like arsenic, cadmium, mercury, lead, and nickel in atorvastatin calcium by open sample digestion technique.…”

Section: Introductionmentioning

confidence: 99%

Determination of arsenic, cadmium, mercury, lead and nickel as elemental impurities in atorvastatin calcium by inductively coupled mass spectrometer

Pal

Sundararajan

2022

Eur J Mass Spectrom (Chichester)

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Atorvastatin calcium is employed as front-line treatment for cardiovascular diseases. According to the international conference on harmonization (ICH) guideline ICH Q3D, elemental impurities can come into drug products from various sources. These elemental impurities do not have any therapeutic benefit to the end-user. On the contrary, it harms the normal physiological system. Class 1 elements like arsenic, cadmium, mercury, and lead are inorganic impurities that can cause toxic effects on the human body. Nickel was used as a catalyst during the synthesis process of atorvastatin calcium. It comes under the Class-2A, can cause toxicity to humans, and must be quantified. A simple, fast, reliable inductively coupled plasma mass spectrometric method for the estimation of elemental impurities like arsenic, cadmium, mercury, lead, and nickel in atorvastatin calcium by open sample digestion technique was developed and validated in accordance with ICH Q3D and USP < 232 > and USP <233 > general chapter. Internal standards like indium, terbium, thallium, bismuth and yttrium were used to correct the non-spectral interferences that were generated during analysis. Gold was added to all solutions as it preserves mercury by amalgamation. The system performance was evaluated every time my performing system suitability parameters. The limits for all the elements were fixed in accordance with ICH Q3D. The limit of detection and the limit of quantification for all the five elements were estimated. Method specificity was proven by checking for interferences due to the sample matrix and other elements. Linearity of each element in standards was established from 25% to 200% of sample concentration, and correlation coefficients were found to be not less than 0.999. The accuracy of the method was demonstrated at three spiking levels at 50%, 100%, and 150% of the J-value for all the elements. The recoveries for all elements at each level were within the range of 90–120%. Method precision was proved at 100% J-value. The relative standard deviation of all elements was less than 5%. It concludes that this newly developed and validated reliable inductively coupled plasma mass spectrometric method for estimating of elemental impurities like arsenic, cadmium, mercury, lead, and nickel in atorvastatin calcium was within the permitted limit and suitable for routine use.

show abstract

Determination of As, Cd, Hg and Pb in continuous use drugs and excipients by plasma-based techniques in compliance with the United States Pharmacopeia requirements

Cited by 13 publications

References 10 publications

Dispersive liquid–liquid microextraction of Cd, Hg and Pb from medicines prior to ICP OES determination according to the United States Pharmacopeia

Dispersive liquid–liquid microextraction of Cd, Hg and Pb from medicines prior to ICP OES determination according to the United States Pharmacopeia

Elemental impurities analysis in name-brand and generic omeprazole drug samples

Determination of arsenic, cadmium, mercury, lead and nickel as elemental impurities in atorvastatin calcium by inductively coupled mass spectrometer

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