Development of Stability Indicating RP-HPLC Method for Tizanidine Hydrochloride in Bulk Drug and Pharmaceutical Dosage Form
Abstract
The quantitative analysis of tizanidine hydrochloride in both pharmaceutical dosage form and bulk medication has been developed and validated using an easy, affordable, quick, and unique isocratic HPLC approach. Tizanidine hydrochloride was separated isocratically using Waters symmetry C18 ODS as the stationary phase (250×4.6 mm, 5μm particle size), a flow rate of 1.0 ml/min, and a UV detector to track the eluate at 230 nm. The drug and its degradation products could be separated using the mobile phase, which was made up of acetonitrile: phosphate buffer (20:80 v/v) and pH-adjusted to 3.0 by ortho-phosphoric acid. Linearity, accuracy (recovery), precision, specificity, and robustness of the approach were all validated. For the range of 4-80 μg/ml, the linearity of the technique was satisfactory (correlation coefficient 0.999). Between 100.4 to 101.3% of the tizanidine hydrochloride was recovered from the medicinal dosage form. In order to analyze the samples, tizanidine hydrochloride was put under stress conditions, including hydrolysis (acid, base), oxidation, photolysis, and heat degradation. The tizanidine hydrochloride forced degradation study demonstrated that it decomposed under minimal conditions. Under the other stress scenarios examined, the medication remained steady. It was discovered that tizanidine hydrochloride was significantly more stable in its solid state than in its solution condition. The breakdown products were clearly distinguishable from the primary peak. The validation method may be useful for routine analysis of tizanidine hydrochloride as bulk drug, in respective dosage forms, for dissolution studies, and as a stability indicating assay method in pharmaceutical laboratories and industries because the forced degradation study proves the method's stability indicating power.
Keywords: RP-HPLC, Tizanidine hydrochloride, Forced degradation, Method validated
Keywords:
RP-HPLC, Tizanidine hydrochloride, Forced degradation, Method validatedDOI
https://doi.org/10.22270/jddt.v13i3.5780References
Moffat AC. Clarks isolation and identification of drugs. 3rd ed. London: Pharmaceutical Press; 2005.
Parfitt K ed. Martindale, The Extra Pharmacopoeia, 36th ed. London: The Pharmaceutical Press; 2009. p. 984.
Merck Index. An Encyclopedia of Chemicals, Drug and Biological, 13th ed. Merck, NJ, USA, 2001.
Zaman M, Hanif M, Murtaza H. Development and validation of RP-HPLC method for simultaneous estimation of tizanidine HCl and meloxicam in bilayer mucoadhesive buccal films. Acta Pol Pharm-Drug Res. 2018; 75(4):851-9. https://doi.org/10.32383/appdr/80742
Pugh J. Kinetics and Product Stability, The Science of Dosage Form Design, Aulton ME, eds. Churchill Livingstone, London, 2002, p. 109.
Carstensen JT. Modus Operendi for Stability Programme, Drug Stability and Practices, Marcel Dekker, Inc., New York, 1995, p.487.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Stability testing of New Drug Substances and Products. QIA (R2), August, 2003.
The United States Pharmacopoeia 30, the National Formulary 25, US Pharmacopeial Convention: Rockville, MD. 2007, Electronic version.
Shankar MB, Shah DA, Geetha M, Mehta FA, Mehta RS, Bhatt KK. Simultaneous spectrophotometric determination of tizanidine and diclofenac in tablets. Ind J Pharm Sci 2004; 66:332-336.
Dahiya R, Chaudhary H, Rathee P, Nagori BP. Spectrophotometric method for the estimation of tizanidine in bulk and tablet dosage forms. Indian Pharmacist 2008; 7:59-62.
Dashora K, Gopal G, Saraf S, Swarnlata S. Spectrophotometric determination of aceclofenac and tizanidine hydrochloride. Asian J Chem 2007; 19:3289-3291.
Ashok K, Kumar R, Anroop B, Tuli k, Gupta AK. Spectrophotometric method for estimation of rofecoxib and tizanidine hydrochloride in tablets. Indian Pharmacist 2007; 6:61-64.
Prabhakar B, Manjunath K, Shobha R, Appala S. Development and validation of spectrophotometric methods for the estimation of tizanidine in pharmaceutical dosage forms. J Ind Council Chem 2005; 22:37-41.
Reddy T, Rama S, Rao SV, Murali M, Rao AN, Sastry CSP. Simple spectrophotometric methods for the determination of tizanidine. J Ind Council Chem 2003; 20:26-29.
Dashora K, Saraf S, Saraf S. Simultaneous spectrophotometric method for the determination of nimesulide and tizanidine hydrochloride. Oriental J Chem 2006; 22:167-168.
Sivasubramanian L, Devarajan. Spectrophotometric and HPLC methods for simultaneous estimation of tizanidine and valdecoxib from tablets. Int J ChemTech Res 2009; 1:96-102.
Kauffmann JM, Ruiz BL, Gotor MF, Patriarche GJ. Electrochemical behaviour of tizanidine at solid electrodes. J Pharm Biomed Anal 1992; 10:763-767. https://doi.org/10.1016/0731-7085(91)80077-M
Tuncel M, Dogrukol D. Study on the polarographic behaviour and determination of tizanidine. Anal Lett 1992; 25:1087-1094. https://doi.org/10.1080/00032719208020061
Bouklouze AA, El Jammal A, Vire JC, Patriarche GJ. Comparative study of three polymeric membrane electrodes selective to tizanidine. Anal Chim Acta 1992; 257:41-48. https://doi.org/10.1016/0003-2670(92)80148-Z
Gunnar T, Mykkanen S, Ariniemi K, Lillsunde P. Validated semiquantitative/ quantitative screening of 51 drugs in whole blood as silylated derivatives by gas chromatography-selected ion monitoring mass spectrometry and gas chromatography electron capture detection. J Chromatogr B 2004; 806:205-219. https://doi.org/10.1016/j.jchromb.2004.04.005
Lee J, Seo JH, Kim DY. Determination of tizanidine in human plasma by gas chromatography- mass spectrometry. Analyst 2002; 127:917-920. https://doi.org/10.1039/b202271k
Kaul N, Dhaneshwar SR, Agrawal H, Kakad A, Patil B. Application of HPLC and HPTLC for the simultaneous determination of tizanidine and rofecoxib in pharmaceutical dosage form. J Pharm Biomed Anal 2005; 37:27-38. https://doi.org/10.1016/j.jpba.2004.09.036
Mahadik KR, Paradkar AR, Agrawal H, Kaul N. Stability indicating HPTLC determination of tizanidine hydrochloride in bulk drug and pharmaceutical formulations. J Pharm Biomed Anal 2003; 33:545-552. https://doi.org/10.1016/S0731-7085(03)00304-2
Pawar UD, Sulebhavikar AV, Naik AV, Pingale SG, Mangaonkar KV. Simultaneous determination of rofecoxib and tizanidine by HPTLC. E J Chem 2009; 6:295-302. https://doi.org/10.1155/2009/674742
Gandhimathi M, Ravi TK, Varghese SJ. Simultaneous LC determination of tizanidine and rofecoxib in tablets. J Pharm Biomed Anal 2005; 37:183-185. https://doi.org/10.1016/j.jpba.2004.09.039
Qi ML, Wang P, Wang L. Validated liquid chromatography method for assay of tizanidine in drug substance and formulated products. Anal Chim Acta 2003; 478:171-178. https://doi.org/10.1016/S0003-2670(02)01525-8
Raman B, Patil D. Reversed phase HPLC for simultaneous estimation of tizanidine and nimesulide in tablets. Indian Drugs 2002; 39:392-394.
Bhoir IC, Raman B, Sundaresan M, Bhagwat AM. Development of an isocratic SFC method for four centrally active muscle relaxant drugs. Anal Lett 1998; 31:1533-1542. https://doi.org/10.1080/00032719808002887
Drug Information Branch (HFD-210), Validation of analytical procedure: Meth-odology. Step 4. In: ICH Harmonized Tripartite Guidelines Q2B. Center for Drug Evaluation and Research, Rockville MD, 6 Nov, 1996.
Bakshi M, Singh B, Singh A, Singh S. The ICH guidance in practice: stress degradation studies on ornidazole and development of a validated stability-indicating assay. J Pharma Biomed Anal 2001; 26(5-6):891-7. https://doi.org/10.1016/S0731-7085(01)00475-7
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