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Experimental Design Approach by Using Rapid High Performance Liquid Chromatographic Method for the Determination of Telmisartan Assay in Immediate Release Telmisartan Tablets 80mg
Corresponding Author(s) : Kasala Vinay kumar
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 12 No. 4 (2024): 2024 Volume -12 - Issue 4
Abstract
A rapid high performance liquid dosage form. A Genesis ODS MG, 50 X 4.6mm, 5 mm or equivalent in isocratic mode, with mobile phase containing a mixture of 0.01 M potassium dihydrogen phosphate buffer (adjusted to pH 2.4 using orthophosphoric acid): methanol: Acetonitrile in the ration of 60:40 v/v) and 0.01 triethylamine : methanol (80:20%v/V) was used. The mobile phase was pumped at a flow rate of 1.0 ml/min and the eluents were monitored at 298 nm. The selected chromatographic conditions were found to effectively separate telmisartan (Rt: 4.98 min) having a resolution of 5.67. The method was validated in terms of linearity, accuracy, precision, specificity, limit of detection and limit of quantitation. Linearity for telmisartan were found okay respectively. The percentage recoveries for telmisartan ranged from 99.45-100.99%, respectively. The limit of detection and the limit of quantitation for telmisartan was found to be 1.5 μg/ml and 3.0 μg/ml, respectively. The method was found to be robust and can be successfully used to determine the drug content of marketed formulations. The method gives resolution with a short analysis time (< 10 min). The method parameter was validated and establishes to be simple, sensitive, accurate and precise. Percentage of recovery shows that the method is free from interference of the excipients used in the formulation. Therefore, the planned method can be used for routine analysis of telmisartan in medical dosage form.
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References
The British Pharmacopoeia. Vol. 2. London: British Pharmacopoeial Commission; 2003. p. 1609. [Google Scholar]
The United States Pharmacopoeia 29, National Formulary 24. Asian Edition. Rockville, MD: United States Pharmacopoeial Convention, Inc; 2006. p. 1890. [Google Scholar]
Baing MM, Vaidya VV, Sane RT, Menon SN, Dalvi K. Simultaneous RP-LC determination of losartan potassium, ramipril, and hydrochlorothiazide in pharmaceutical preparations. Chromatographia. 2006;64:293–6. [Google Scholar]
Rao KV, Vijaya Kumari K, Bhanuprakash I, Prabhakar G, Begum J. Determination of ramipril in pharmaceutical dosage forms by reversed-phase liquid chromatography. Asian J Chem. 2006;18:788–92. [Google Scholar]
Belal F, Al-Zaagi IA, Gadkariem EA, Abounassif MA. A stability-indicating LC method for the simultaneous determination of ramipril and hydrochlorothiazide in dosage forms. J Pharm Biomed Anal. 2001;24:335–42. [PubMed] [Google Scholar]
Rao RN, Sen S, Nagaraju P, Reddy VS, Radha Krishnamurthy P, Udaybhaskar S, et al. HPLC determination of Telmisartan in bulk and pharmaceutical formulations. Asian J Chem. 2006;18:775–82. [Google Scholar]
Palled MS, Rajesh PM, Chatter M, Bhat AR. RP-HPLC determination of Telmisartan in tablet dosage forms. Indian J Pharm Sci. 2005;67:108–10. [Google Scholar]
Kumar MV, Muley PR. Stability indicating RP-HPLC method for determination of Telmisartan in solid dosage forms. Indian Pharmacist. 2005;4:69–72. [Google Scholar]
ICH, Q2B- Validation of Analytical Procedures: Methodology, International Conference on Harmonization. 1996. Nov,
Pei Liu, Bo Sun, Xiumei Lu, Feng Qin, Famei Li., HPLC determination and pharmacokinetic study of tenatoprazole in dog plasma after oral administration of enteric-coated capsule., Biomedical chromatopgraphy., 2007, 21:89-93
Sunil R. Dhaneshwar. Vidhya K. Bhusari. Mahadeo V. Mahadik. B. Santakumari., Application of a Stability-Indicating Thin-Layer Chromatographic Method to the Determination of Tenatoprazole in Pharmaceutical Dosage Forms., Journal of AOAC international.,2009, 92 (2):387-393.
Nirogi R, Kandikere V, Mudigonda K, Bhyrapuneni G., Quantification of tenatoprazole in rat plasma by HPLC:validation and its application to pharmacokinetic studies.,Chromatogram.,2007, 21(12):1240-4.
Sethi, P.D. HPLC Quantitative Analysis of Pharmaceutical Formulations. 1st edition., CBS publisher and Distributors, New Delhi, 2001, 5-10
Llyod, R., Synder., Joseph, K., Kirkl., Joseph., and L. Glajch. Practical HPLC Method Development. 2nd edition., Wiley –Interscience Publication, New york, 1997, 45
Anonymous. Shimadzu LC-10 ATVP High performance liquid chromatography InstructionManual, Shimadzu Corporation., Kyoto, Japan, 2001, 11-2.
Shin JM, Choo YM, Sachs G. Aliment PharmacolTher., Blackwell Publishing Ltd, 2006, 2-8.
Sharma, B.K. Instrumental Methods of Chemicals Analysis. 13th edition.,Goel Publisher House, Meerut, 1994, 7.
Mendham, J., Denny, R.C., Barnes, J.D. and Thomas, M.J.K. Vogel’s, Text book of Quantitative Chemical Analysis. 6th edition., Pearson Education Pvt. Ltd., New Delhi, 2002, 261- 263,268,277,653,654
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Code Q2A, Text on Validation of Analytical Procedures. ICH Tripartite Guidelines,Geneva, Switzerland, 27 October, 1994, 1 - 5.
Code Q2B, Validation of Analytical Procedures; Methodology. ICH Tripartite Guidelines, Geneva, Switzerland, and 6th November, 1996, 1 - 8.