Development and validation of ICPMS methods for simultaneous determination of elemental impurities in topical cream containing ximenynic acid

Abstract

Abstract Background These days, the presence of simple impurities in pharmaceuticals is a major cause for worry. This is because some contaminants are dangerous on their own, and even small impurities can make a drug less stable and shorten its shelf life. The goal of this study was to see if creams with ximenynic acid could be tested with inductively coupled plasma-mass spectrometry to find out how much arsenic, mercury, lead, cadmium, vanadium, cobalt, and nickel were in them. The best way to do things would be one that was quick, accurate, sensitive, and very productive (ICP-MS). The method included both inductively coupled plasma mass spectrometry (ICP-MS) and microwave digestion. Results Seven of the seven linearity correlation coefficient (‘R’) value were more than 0.99. LOD values were calculated using 33% of the 0.25 J threshold. Six LOQ responses (0.25 J level) were taken after considerable discussion. Calculated and reported %RSD for six LOQ copies. All elemental impurities Vanadium (V), Cobalt (Co), Nickel (Ni), Arsenic (As), Cadmium (Cd), Mercury (Hg), and Lead (Pb) were recovered between 83.33% and 115.97%, within acceptability limits. RSD% for procedure precision and intermediate precision data never exceeded 5%. The available evidence shows that the ICP-MS technique is a good way to measure these components. Conclusion The statistical analysis showed that the developed ICP-MS method for measuring elements in Topical Cream with Ximenynic Acid is selective and accurate. Since this ICPMS method is good at estimating several elements simultaneously, it could be used to check for elemental contaminants in the formulation.

Keywords

• ICPMS
• MWAD
• Elemental impurities
• Validation
• Topical cream containing ximenynic acid