P. Suresh, Konda Ravi Kumar
P. Suresh1*, Konda Ravi Kumar2
1Vishwa Bharathi College of Pharmaceutical Sciences, Perecharla-522009, A.P., India.
2Department of Pharmaceutical Chemistry, Hindu college of Pharmacy, Guntur, India.
Volume - 14,
Issue - 3,
Year - 2021
The aim of the present work is to develop and establish a validated analytical method for the determination of arsenic, cadmium, mercury, lead and palladium content in testosterone propionate by using inductive coupled plasma mass spectroscopy (ICP-MS). Samples were analyzed after a preparation of sample solution by dissolving in suitable solvents of concentrated nitric acid and concentrated hydrochloric acid. In the present method, RF power of 1550 watts, RF matching is 1.80 V, nebulizer flow of 0.10 rps and plasma view at spectrum mode were used. Octopole conditions are He flow is on, He flow rate is 4.3 mL/min and energy discrimination is 3.0 V were used. Significant savings in sample volumes, reagents, analysis cost and time are realized. Arsenic, cadmium, mercury, lead and palladium are primary concerned due to their high toxicity and potential contaminants should be limited in testosterone propionate and the developed method was validated according to ICH and USP guidelines. The correlation coefficient, recovery rate, LOD and LOQ reached the acceptable limits. The validated method was selective, sensitive, rapid and capable of the determination of elemental impurities of arsenic, cadmium, mercury, lead and palladium content in bulk drugs.
Cite this article:
P. Suresh, Konda Ravi Kumar. Determination of elemental impurities of Arsenic, Cadmium, Mercury, Lead and Palladium content in Testosterone propionate by using ICP-MS. Asian Journal of Research in Chemistry. 2021; 14(3):195-2. doi: 10.52711/0974-4150.2021.00035
P. Suresh, Konda Ravi Kumar. Determination of elemental impurities of Arsenic, Cadmium, Mercury, Lead and Palladium content in Testosterone propionate by using ICP-MS. Asian Journal of Research in Chemistry. 2021; 14(3):195-2. doi: 10.52711/0974-4150.2021.00035 Available on: https://ajrconline.org/AbstractView.aspx?PID=2021-14-3-7
1. Nieschlag E., Behre H.M., Bouchard P., et al. Testosterone replacement therapy: Current trends and future directions. 2004; 10: 409-419.
2. Seal L.J. Male hypogonadism and testosterone replacement therapy, Medicine. 2013; 41(10): 557-561.
3. Molrley J.E., Charlton E., et al. Validation of a screening questionnaire for androgen deficiency in aging males, Metabolism. 2000; 49: 1239-1242.
4. Kelleher S., Conway A.J., Handelsman D.J. Blood testosterone threshold for androgen deficiency symptoms, J. Clin. Endrocrinol. Metab. 2004; 89: 3813- 3817.
5. Mulligan T., Fricks M.F., et al. Prevalence of hypogonadism in males aged at least 45 years: The HIM study, Int. J. Clin. Pract. 2006; 60(7): 762-769.
6. S. M. Enamorado-Báez,1,2 J. M. Abril,2 and J.M. Gómez-Guzmán3, Determination of 25 Trace Element Concentrations in Biological Reference Materials by ICP-MS following Different Microwave-Assisted Acid Digestion Methods Based on Scaling Masses of Digested Samples. Analytical Chemistry, 2013, http://dx.doi.org/10.1155/2013/851713, 1-14.
7. Neha Nath, G.N. Singha, R.M. Singha, Kanchan Kohlib, Cadmium, lead, arsenic and mercury detection and validation by inductively coupled plasma-mass spectroscopy in different cultivars of mango (Mangifera indica I.) fruit pulp, Journal of Pharmacy Research. 2011; 4(10):3466-3471.
8. Bonnie Mei Wah Fong, Tak Shing Siu, Joseph Sai Kit tee, and Sidney Tam, Determination of Mercury in Whole Blood and Urine by Inductively Coupled Plasma Mass Spectrometry, Journal of Analytical Toxicology, Vol. 31, June 2007, https://academic.oup.com/jat/article-abstract/31/5/281/775618 by guest on 12 December 2019.
9. Matti. Niemela, Harri Kola, Paavo Peramaki, Derermination of trace Impurities in Germanium oxide by ICP-OCES, ICP-MS and ETAAS after matrix volatilization. Analytical Sciences, 2014, 30, 1, 735-738.
10. Kozlik P. and Tircova B. Development of fast, simple and fully validated high performance liquid chromatographic method with diode array detector for quantification of testosterone esters in a oil-based injectable dosage form, Steroids. 2016; 115: 34-39.
11. Guercia C., Cianciullo P. and Porte C. Analysis of testosterone fatty acid esters in the digestive gland of mussels by liquid chromatography-high resolution mass spectrometry, Steroids. 2017; 123: 67-72.
12. Nielen M.W.F., Lasaroms J.J.P., Mulder P.P.J., et al. Multi residue screening of intact testosterone esters and boldenone undecylenate in bovine hair using liquid chromatography electrospray tandem mass spectrometry, J. Chromatogr. B. 2006; 126-134.
13. Amber Bharti, Christine Jeyaseelan. Quantification of potential impurities present in testosterone undecanoate active pharmaceutical ingredient by stability indicating HPLC method using UV detector. Jordan Journal of Pharmaceutical Sciences. 2019; 12(1): 11-19.
14. International Council for Harmonization (ICH), Q3A (R2): Impurities in New Drug Substances, Step4, 2006.
15. International Council for Harmonization (ICH), Q1A (R2): Stability Testing of New Drug Substances and Products, Step4, 2003.
16. International Council for Harmonization (ICH), Q1B: Photo Stability Testing of New Drug substances and Product, Step4, 1996.
17. International Council for Harmonization (ICH), Q2 (R1): Validation of analytical Procedure: Text and Methodology, Step4, 2005.