Development and Validation of Stability-Indicating High Performance Liquid Chromatographic Method for Determination of Tetramisole Hydrochloride in Pharmaceutical Formulation
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Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University,11751, Nasr City, Cairo, EGYPT
Online publish date: 2018-06-02
Publish date: 2018-06-02
Eurasian J Anal Chem 2018;13(4):em36
Development of simple and selective stability-indicating HPLC method for determination of tetramisole hydrochloride in presence of its degradation products.

Analysis was performed on SUPELCO C18 column (250mm length, 4.6mm width, 5μm particle size) using acetonitrile : methanol : water (50:33:17, by volume) as a mobile phase. The analysis process was carried out at ambient temperature with flow rate of 1 mL/min and the separated peaks were detected by UV at 212 nm. Drug was exposed to forced degradation condition like hydrolysis, oxidation, thermal and photolysis.

Method can well resolve all degraded product as compare to tetramisole hydrochloride. The method has been linear for the range of 1 – 6 μg/mL with r2 0.9997.

This work focused on study of the stability of tetramisole hydrochloride and its behavior when exposed to different stress conditions. The proposed method was successfully applied for determination of tetramisole hydrochloride in pharmaceutical preparation without interference from excipients or degradation products and the method was found to be valid according to International Conference on Harmonization (ICH) guidelines.

1. Sweetman SC. Martindale, the complete drug reference 36th Ed., Pharmaceutical Press, London, UK, 2009.
2. Sane RT, Sapre DS, Nayak VG. An extractive spectrophotometric method for the determination of tetramisole hydrochloride in pharmaceutical preparations; Talanta. 1985;32:148–149.
3. Amin AS, Dessouki HA. Facile colorimetric methods for the quantitative determination of tetramisole hydrochloride; Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2002;58:2541–2546.
4. Sastry CSP, Aruna M, Reddy MN, Sankar DG. Extractive spectrophotometric determination of some anthelmintics using fast green FCF or orange-II; Indian Journal of Pharmaceutical Science. 1988;50:140–142.
5. Amin AS. Quantitative determination of some pharmaceutical veterinary formulations using bromocresol purple and bromocresol green; Analytical Letters. 2006;30:2503–2513.
6. Patil H, Wani M, Kuchekar BS. Development and validation of UV-spectrophotometric method for the estimation of tetramisole hydrochloride in bulk and pharmaceutical dosage form; Indo American Journal of Pharmaceutical Research. 2014;4:1903–1909.
7. Nassar MWI, Attia KAM, Mohamad AA, Said RA, Abdel-monem AH. Development and validation of spectrophotometric methods manipulating ratio spectra for determination of tetramisole hydrochloride in the presence of its alkali-induced degradation product Journal of analytical & pharmaceutical research. 2018;7(1):67-72.
8. Gupta VK, Singh AK, Gupta B. Potentiometric sensor for the high throughput determination of tetramisole hydrochloride; Combinatorial Chemistry & High Throughput Screening. 2007;10:583–594.
9. Issa YM, Rizk MS, Shoukry AF, Abdel-Aziz R, Abdel-Fattah HM, Atia EM. Construction and performance characteristics of new tetramisole selective plastic membrane electrodes; Talanta. 1994;41:135–141.
10. Holbrook A, Scales B. polarographic determination of tetramisole hydrochloride in extracts of animal tissue. Analytical Biochemistry. 1967;18:46-53.
11. Wagh JS, Mokashi AA, Datta A. High-performance liquid chromatographic method for the monitoring of the synthesis of the precursor for tetramisole; Journal of Chromatography. 1993;644:428–433.
12. Mourot D, Delepine B, Boisseau J, Gayot G. High-pressure liquid chromatographic analysis of veterinary anthelmintics I: quantitative determination of tetramisole; Journal of Pharmaceutical Sciences. 1979;68:796–797.
13. Bertuccia C, Tedescoa D, Fabinia E, Di Pietraa AM, Rossib F, Garagnanib M, Borrellob ED, Andrisano V. Determination of levamisole and tetramisole in seized cocaine samples by enantioselective high-performance liquid chromatography and circular dichroism detection. Journal of Chromatography. 2014;1363:150–154.
14. The United States Pharmacopeia, National Formulary 35, United States Pharmacopeia Convention Inc., 30th edn, 2012.
15. International Conference on Harmonization. Validation of Analytical Procedures: Text and Methodology Q2 (R1), Current step 4 version. 2005.