Volume : 09, Issue : 09, September – 2022
17.DETERMINATION OF ELEMENTAL IMPURITIES IN CLOMIPRAMINE HYDROCHLORIDE CAPSULES USP 25MG, 50MG AND 75MG BY INDUCTIVE COUPLED PLASMA MASS SPECTROMETRY (ICP-MS).
Dr. Rahul Kumar, Rahul Dev, Dr. Kunwar Sanjeev Singh, Dr. Anil Tyagi, Hari Darshan Singh, Pushpendra Singh, Ankur Vaish & *Dr. Shaily Raizada
Determination of elemental impurities “Cadmium, Lead, Arsenic, Mercury, Cobalt, Vanadium and Nickel” in Clomipramine Hydrochloride capsules USP by Inductive coupled plasma mass spectrometer (ICP-MS). The Microwave digester system, Nitric acid and Hydrogen peroxide were used for sample preparation. specified limit of elemental impurities in Clomipramine Hydrochloride Capsule USP (25mg, 50mg, 75mg,) are taken from ICHQ3D.
The validation parameters and acceptance criteria were carried out in accordance with USP general chapter <232), <233> and ICHQ3D. During validation specific, precise, linear, accurate, rugged and LOD-LOQ parameters were performed. Range of the validated method is LOQ to 200% of specification level for each elemental Impurities. The limit of detection and limit of quantification are 8.33% and 25% of specification level for each elemental impurity. The validated method was effectively useful to determine the elemental impurities in Clomipramine Hydrochloride capsules USP
Keywords: Inductive coupled plasma mass spectrometer (ICP-MS), Clomipramine Hydrochloride Capsule USP, Elemental impurities, ICH guideline.
Cite This Article:
Please cite this article in Rahul Kumar et al, Determination Of Elemental Impurities In Clomipramine Hydrochloride Capsules USP 25mg, 50mg And 75mg By Inductive Coupled Plasma Mass Spectrometry (ICP-MS)., Indo Am. J. P. Sci, 2022; 09(9).
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1. ICH Q2 (R1) Validation of Analytical Procedures: Definitions and Methodology, Geneva, 2005, in 2005 incorporated in Q2 (R1).
2. International Conference on Harmonization (ICH) Harmonized Tripartite Q3D Step 4 Guideline, Guideline for Elemental Impurities, Q3D, 2019, 1-86.
3. United States Pharmacopeia (USP), Elemental Impurities General Chapters Limits and <233> Procedures.
4. Zaidi K. Heavy metals and elemental impurities-limits/procedures, In United States Pharmacopeia, USP41-NF36, Chapter 231, 232 and 233, 4, 2018, 6145-6155.
5. Im Zaidi K. Plasma spectrochemistry, In United States Pharmacopeia, USP41–NF36, Chapter 730/1730, 5, 2018, 6482-6485/7956- 7963.
6. Guidance for Industry, In United States Department of Health and Human Services Food and Drug Administration, Procedures and methods validation for drugs and biologics, Pharmaceutical Quality/CMC, United States, 2015, 1-15.
7. Horacio N. Pappa. Validation of compendia procedures, In United States Pharmacopeia, USP41–NF36, Chapter 1225, 5, 2018, 7665- 7671
8. Validation of analytical procedures, In International Conference on Harmonization, Q2 (R1), Current Step 4 version, 2005, 1-13.
9. ICH M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to limit potential Carcinogenic Risk, Business plan 2010. Position paper 2010.
10. Method Development and Validation of 2-[(2-Methoxyphenoxy) Methyl] Oxirane Content In Ranolazine Drug Substance By LC-MS/MS. Journal of Chemistry and Chemical Sciences, Vol.10(12), 377-388, December, 2020.
11. Method Development and Validation of Epichlorohydrin content in Ranolazine drug substance by GC-MS/MS. Asian Journal of Research in Chemistry and Pharmaceutical Sciences. 8(3), 306-316, 2020.
12. Method Development and Validation 0f N, N dimethylaminopropyl Chloride (DMPC) Content in Clomipramine Hydrochloride Drug Substance By GC-MS/MS. Asian Journal of Research in Chemistry and Pharmaceutical Sciences. 9(3), 121-131, 2021.
13. Quantitative Evaluation of N-Nitrosamine Impurities in Telmisartan Tablets USP 20mg, 40mg and 80mg by Gas Chromatography Coupled with Mass Spectrometer. Indo American Journal of Pharmaceutical Sciences. 09 (8), 77-93, 2022.
14. Method Development and Validation for Quantification of Residual Solvents in Atorvastatin Calcium Drug Substance by GC-HS Using Fid Detector. Journal for Research in Applied Sciences and Biotechnology. Vol.-1(3), 186-194, August, 2022.