Author(s):
Naga Jhansi Tamanampudi, Naga Raju Rajana, Pavan Kumar Dharmasanam, Jaya Deep Kumar Lilakar, Nageswara Rao Gollapalli
Email(s):
jhansireddyau@gmail.com , tnagajhansi@drreddys.com
DOI:
10.5958/0974-4150.2020.00047.4 
Address:
Naga Jhansi Tamanampudi1,2*, Naga Raju Rajana1,2, Pavan Kumar Dharmasanam1,2, Jaya Deep Kumar Lilakar1, Nageswara Rao Gollapalli2
1Department of Analytical Research and Development, Reddy’s Laboratories Ltd., Visakhapatnam, 530045, Andhra Pradesh, India.
2Department of Inorganic and Analytical chemistry, Andhra University, Visakhapatnam, 530003, Andhra Pradesh, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 4,
Year - 2020
ABSTRACT:
This study describes the development and quantification of reverse phase HPLC method for the genotoxic impurity i.e. 2- (dimethyl amino) thioacetamide commonly named as DIS. It is one of the key raw material for the synthesis of Nizatidine product. There is no method is available for the determination of DIS in any active pharmaceutical ingredients/drug substance. After several development trials, DIS quantification at extremely low level was accomplished on YMC PACK ODS A, 15cm x 4.6mm, 3.0µm column using the combination of sodium acetate and n-Heptane sulfonic acid sodium salt with additives of Acetic acid and Tri ethyl amine as buffer and acetonitrile as organic modifier. Diluent was selected as water. The flow was selected as 1.5mL/min and temperature of column was maintained at 35°C. The wavelength was selected at 254nm and injection volume was 10µL. The limit of detection and limit of quantification were 20ppm and 50ppm respectively. The method was validated and found to be precise, accurate and robust. The method can be used for determination of 2- (Dimethyl amino) thioacetamide, which is the key starting material for preparation of Nizatidine.
Cite this article:
Naga Jhansi Tamanampudi, Naga Raju Rajana, Pavan Kumar Dharmasanam, Jaya Deep Kumar Lilakar, Nageswara Rao Gollapalli. Novel RP-HPLC method for quantification of 2-(dimethyl amino) thioacetamide impurity in Nizatidine drug substance. Asian J. Research Chem. 2020; 13(4):243-248. doi: 10.5958/0974-4150.2020.00047.4
Cite(Electronic):
Naga Jhansi Tamanampudi, Naga Raju Rajana, Pavan Kumar Dharmasanam, Jaya Deep Kumar Lilakar, Nageswara Rao Gollapalli. Novel RP-HPLC method for quantification of 2-(dimethyl amino) thioacetamide impurity in Nizatidine drug substance. Asian J. Research Chem. 2020; 13(4):243-248. doi: 10.5958/0974-4150.2020.00047.4 Available on: https://ajrconline.org/AbstractView.aspx?PID=2020-13-4-1
REFERENCES:
1. https://en.wikipedia.org/wiki/Nizatidine
2. https://pubchem.ncbi.nlm.nih.gov/compound/Nizatidine
3. Atmaca M, Kuloglu M, Tezcan E, Ustundag B, Kilic N. Nizatidine for the treatment of patients with quetiapine-induced weight gain. Hum Psychopharmacol, 2004; 19(1); 37-40.
4. Parente F, Porro GB. Acid Inhibitory Characteristics of Nizatidine in Man: An Overview. Scandinavian Journal of Gastroenterology, 1994; 29(206); 3-7.
5. Minic D, Petkovic J, Koricanac Z, Jovanovic T. Spectrophotometric determination of nizatidine in pharmaceutical preparations. Journal of Pharmaceutical and Biomedical Analysis, 1996; 14 (8); 1355-1358.
6. Al-Ghannam S, Belal F. Spectrophotometric Determination of Three Anti-Ulcer Drugs Through Charge-Transfer Complexation. Journal of AOAC international, 2002; 85(5): 1003-1008.
7. El-Yazbi FA, Gazy AA, Mahgoub H, El-Sayed MA. Youssef RM. Spectrophotometric and titrimetric determination of nizatidine in capsules. Journal of pharmaceutical and biomedical analysis, 2003; 31(5): 1027-1034.
8. Youssef RM. Validated stability-indicating methods for the determination of nizatidine in the presence of its sulfoxide derivative. J AOAC International. 2008; 91(1): 73-82.
9. Koricanac Z, Jovanovic T, Stankovic B. Determination of nizatidine in pharmaceutical formulations by potentiometric titration. Pharmazie, 1995; 50(2): 151-152.
10. El-Gendy AE, El-Bardicy MG, Loutfy HM, El-Tarras MF. Stability indicating method for the method determination of Nizatidine using 3-methyl -2-benzothiazolonone hydrazone. Spectroscopic letters, 2001; 34(2): 221-234.
11. Antony Raj Gomes, Pannala Raghuram, Sriramulu J, Nimmakalaya Srinivas. Rapid Validated Stability Indicating Method for Nizatidine and Its Impurities Quantification. American Journal of Analytical Chemistry, 2011; 2(3); 314-323.
12. Shabir GA. Validation of high-performance liquid chromatography methods for pharmaceutical analysis. Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. Journal of Chromatography A, 2003; 987 (1–2): 57-66.
13. Q2 (R2)/Q14 EWG, 2018, Analytical procedure development and revision of Q2 (R1) analytical validation.
14. ICH, Q7, 2000, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.