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

Abstract

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.

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

“…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.…”

“…Sample preparation for drugs in solid dosage form was performed based on previously proposed works for microwave-assisted sample digestion 26,27 . All samples were ground and homogenized using pestle and mortar and masses of approximately 500 mg were microwaveassisted digested in triplicate using a volume of 7 mL of 2 mol L -1 HNO 3 .…”

Aerosol dilution for the introduction of complex matrix samples in plasma-based spectrometry techniques: a tutorial review

“…By using this conguration and according to the reviewed papers, ow rates of 0.1 L min À1 to 2.0 L min À1 are possible for the dilution gas. This device was used in some works to either reduce the impact of high TDS samples to the ICP-MS or to determine elements in high concentrations in samples such as waters 24 and drugs, [25][26][27] applying a total carrier gas ow rate of 1.0 L min À1 . Pinheiro et al demonstrated that, with the aid of HMI and He collision cell, high concentration elements in waters, such as Na, K, Ca, and Mg could be determined along with trace levels of contaminants such as Cd, Hg, Pb, and U in a single run.…”

“…In this way, AD has been used by some authors as a sample introduction procedure to reduce matrix interferences in drug analysis by ICP-MS (Table 3). 25–27,64–67…”

“…Pinheiro et al published two papers focused on drug analysis 27,66 and one for dietary supplement, 26 using AD ICP-MS, setting nebulization and dilution gas flow rates at 0.62 L min −1 and 0.40 L min −1 , respectively. Microwave-assisted acid decomposition was employed in these three papers.…”