DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND HYDRO-CHLOROTHIAZIDE IN BULK DRUG AND PHARMACEU-TICAL DOSAGE FORM BY UV- SPECTROPHOTOMETRY
Keywords:
Telmisartan, Hydrochlorthiazide UV Visible SpectroscopyAbstract
A simple, accurate and precise simultaneous analytical method has been developed for simultaneous determination of Telmisartan and Hydrochlorothiazide in bulk drug and tablet dosage form. The wavelength selected for these drugs were 295.5 nm and 273.0 nm respectively. The linearity at selected wavelength lies between 10-90 µg/ml for Telmisartan and 5-60 µg/ml for Hydrochlorothiazide. The concentrations of these drugs were evaluated in laboratory mixture of reference standard and different marketed formulation. Recovery studies confirmed the accuracy of proposed method. Precision of the method was found as the values within acceptable limit. Thus the proposed method and results were validated as per ICH guidelines. Statistical analysis proves that the method is reproducible and selective for the simultaneous estimation of Telmisartan and Hydrochlorothiazide.
Downloads
References
Dr.Atul Patel, “Development and Validation of DeriVative spectroscopic method for simultaneous Determination of Nebivolol Hydrochloride and S-Amlodipine Besylate in combined Dosage form”, IJPBS,2013 July,4(3),p.n.379-391
N.B.Gotecha, “Simultaneous Estimation of Acyclophenac and Thiocholchicoside in pharmaceutical Dosage form by Spectrophotometric Method,”2013 July,4(3),p.n.778-785
Christian G. D., Analytical Chemistry, John Wiley and Sons:2003, 6th ed., pp.1-3, p.n. 604-620.
Skoog D. A., Holler F. J., Timothy A., Nieman T. A., Principles of Instrumental Analysis, Banglore, Eastern Press, 2004, 5th ed., p.n.1-2, 678-688, 695-696.
Mendham J., Denney R. C., Barnes J.D., Thomas M., Vogel’s Textbook of Quantitative Analysis. Pearson Education, Singapore, 2003, p.n. 8-9.
Beckett A. H., Stenlake J. B., Practical Pharmaceutical Chemistry, Part- 2, New Delhi, CBS Publishers and Distribu-tors:2002, 4th ed., p.n. 275-300, 157-165.
Kalasi P. S., Spectroscopy of Organic Compound, New Delhi, New age International Publishers, 2007, 6th.ed., p.n.7-10.
Chatwal G. R., Anand S. K., Instrumental Methods of Chemical Analysis, Himalaya Publishing House, 2005, 5th.ed., p.n.1.1-1.2, 2.149-2.184, 2.624- 2.639.
Sethi P. D. , High Performance Liquid Chromatography, Quantitative Analysis of Pharmaceutical Formulations, CBS Publishers and Distributors, New Delhi, 2001, 1th. ed., p.n.3-41, 415-421.
Willard H. H., Merritt L.L., Dean J. A., Instrumental Methods of Analysis , New Delhi, CBS Publishers and Distributors , 2001,7th.ed., p.n.1-12,177-178,580-608.
Mahadik K. R., Kasture A.V., Wadodkar S. G. , More H. N. , Pharmaceutical Analysis-Instrumental Methods, Vol. 2, Nirali Prakashan, p.n. 6,7,64,67,28-30,49.
Jeffery G. H., Bassat J. Mendham J., Denny R. C., Vogel’s Textbook of Quantitative Chemical Analysis, Elbs With Longman Publication, Harlow, 1989, 5th ed., p.n.- 1,3,6.
Sharma B. K., Instrumental Methods of Chemical Analysis, Goal Publishing House, Meerat, 2007, 5th ed., p.n.- 68-192.
Haider S. I., Validation of Standard Operating Procedures, 2nd ed., p.n.- 449.
United States Pharmacopoeia, National Formulary, 2004, The Official Compendia Std., p.n.- 731-736.
ICH, Q2A, Text on Validation of Analytical Procedures, International Conference on Hormoniza-tion,Geneva,Oct.1994, p.n.1-5.
ICH, Q2B, Validation of Analytical Procedures: Methodology, International Conference on Harmonization, Geneva, Nov.1996, p.n.1-8.
Indian Pharmacopoeia, 2007, Volume-2, Government of India, Ministry of Health and Family Welfare, Published by- The Indian Pharmacopoeial Commission, Ghaziabad, p.n. 1196.
Tripathi K. D., Essentials of Medical Pharmacology , Jaypee Brother Medical Publishers (P) Ltd.,6ed.,p.n.542, 543, 565,.
British Pharmacopoeia, 2010, Published by MHRA : 6th ed. Of the European Pharmacopoeia,Volume-3, pp. 2481.
Martindale, The Complete Drug Reference, 36th Edition, Vol. 1, Edited by Sean C. Sweetman, pp.1307.3, 1409.2.
The Merck Index, An Encyclopedia of Chemicals, Drugs and Biologicals, Published by Merck Research Laboratories, Division of Merck and Co. Inc. 13th Edition, p. n. 4802, 9209.
Published
How to Cite
Issue
Section
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright © Author(s) retain the copyright of this article.
