A validated HPTLC method for estimation of Nitazoxanide in bulk and formulation

Obaid Shaikh; Sarfaraz Khan; Zahid Zaheer; Younus Shaikh; Madhukar Tajne

Obaid Shaikh Department of Quality Assurance, Y.B. Chavan College of Pharmacy, Aurangabad, India.
Sarfaraz Khan Department of Quality Assurance, Y.B. Chavan College of Pharmacy, Aurangabad, India.
Zahid Zaheer Department of Quality Assurance, Y.B. Chavan College of Pharmacy, Aurangabad, India.
Younus Shaikh Department of Quality Assurance, Y.B. Chavan College of Pharmacy, Aurangabad, India.
Madhukar Tajne University Department of Pharmaceutical Sciences, RTM Nagpur University, Nagpur, India.

Abstract

A simple, specific, accurate, reproducible and precise high performance thin layer chromatographic method was developed for estimation of Nitazoxanide (NTZ) in pharmaceutical formulation. This method involved Camag high performance thin layer chromatography (HPTLC) system comprising of Linomat IV sample applicator with Merck precoated aluminium sheets Silica Gel 60 F254 of 10 x 10 cm size and 200 mm thickness. The mobile phase consisting of ethyl acetate : iso-octane (5 : 5 v/v). The detection was carried out densitometrically using UV detector in absorbance mode at 360 nm. The Rf value was 0.44, proving good resolution. The method is sensitive to detect Nitazoxanide (NTZ). The correlation coefficient was >0.99. The method was validated for accuracy, precision, specificity, linearity, range, ruggedness and robustness. The proposed method was successfully used to determine the drug content of marketed formulation.

Keywords: Nitazoxanide, HPTLC, validation

Downloads

Download data is not yet available.

References

1. Rossignol, Jean, Francois; PCT. Intl. Appl. Wo, 95- 28, 393(Cl.Co 7D277 / 58), 26th Oct. 1995. US. Appl. 227, 033, 13th Apr. 1994, 45 PP / C. A. 124 1996 # 176078z.
2. Rossignol, Jean, Francois; Cavier, Raymond; Ger. Offen. 2,438, 037 (Cl. Co 7 D) 20thFeb. 1975. Brit. Appl. 37, 608 / 73, 08th Aug 1973, 11 PP / C.A. 83 1975 # 28216n.
3. Rossignol F, Hidalgo H, Ferigrino M; Higuera F; Gomez H; Romero L; Padierna J; Geyne A; Ayers S. A double blind placebo controlled study of nitazoxamide in the treatment of cryptosparidial diarrhea in AIDS patients in mexica. Trans. R. Soc. Trop. Med. Hyg. 1998; 92(6):663-666.
4. Rossignol F; Stachulski V. Synthesis and antibacterial activities of tizoxanide and its o-aryl glucuronide. J. Chem. Res. Synop. 1999; (1):44-45.
5. Romero Cabello, R, Guerrero, L. R., Munoz Garcia, M. R. and Geyne Cruz, A. “Nitazoxanide for the treatment of intestinal protozoal and helmenthic infections in Mexico”. Trans. Royal Soc. Trop. Med. Hyg. 1997; 91:701-3.
6. Doumbo, O., Rossignol F., Pichard, E., Traore A., Dembele M.,Diakite. Nitazoxanide in the treatment of Cryptosporidial diarrhoea and other intestinal parasitic infections associated with acquired immunodeficiency syndrome in tropical Africa. American journal of tropical Medicine and Hygiene 1997; 56:637-9.
7. Dubreuil, L., Houcke, i., Mounton, Y. and Rossignol F. In-vitro evaluation of activities of Nitazoxanide and Tizoxanide against anaerobes ad aerobic organisms. Antimicrobial agents and chemotherapy 1996; 40:2266-70.
8. Rossignol, J. F. and Maisonnueve, H. Nitazoxanide in the treatment of Taenia saginata and Hymenolepis nana infections. American journal of Tropical Medicine and Hygiene 1984; 33:511-2.
9. Stockis, A; Allemon, A, M; De Bryun, S; Gangler, C; Intl. Jour. Clin. Pharm. & Therap. 2002. 40 (5) 213-220 / C. A. 138 2003 # 49350w.
10. “British Pharmacopoeia”, ‘British Approved Names’ The Department of Health, Social Services and Public Safety, Her Majesty Stationary Office, London 2002; 198.
11. “The Merck Index” by Merck & Co. Inc, Whitehouse Station. NJ, USA, 1999, Monograph No. 10377.
12. http//rxlist.com/cgi/generic3/alinia.htm.
13. Indian Pharmacopoeia, Published by controller of publication Delhi 1996; 2: A-144.