Development and validation of an RP-HPLC method for simultaneous analysis of a three-component tablet formulation containing metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide
Wybrane pełne teksty z tego czasopisma
A simple, rapid, and precise reversed-phase high-performance liquid chromatographic method for simultaneous analysis of metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide in a tablet dosage form has been developed and validated. Chromatography was performed on a 25 cm × 4.6 mm i.d., 5-µm particle, C 18 column with 55:45 ( v/v ) acetonitrile - potassium dihydrogen phosphate buffer (pH adjusted to 3.0 š 0.1 with 5% orthophosphoric acid) as mobile phase at a flow rate of 1.5 mL min ?1 . UV detection was performed at 230 nm. Total run time was 10 min; metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide were eluted with retention times of 1.362, 3.418, and 7.395 min, respectively. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the concentration ranges 200-1000µg mL -1 for metformin hydrochloride, 200-1000 µg mL -1 for pioglitazone hydrochloride, and 50-300 µg mL -1 for glibenclamide. Limits of detection were 6.3, 15.4, and 8.2 ng mL -1 and limits of quantification were 19.09, 46.66, and 24.84 ng mL -1 for metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide, respectively. The high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of the three drugs in tablets. The validated method was successfully used for quantitative analysis of triglycomate tablets.
Bibliogr. 13 poz., rys., tab.
-  British Pharmacopoeia, Vol. I, HMSO, London, 2002, p. 1123
-  Martindale — The Complete Drug Reference, Pharmaceutical Press, London, 2002, pp. 33, 323.3
-  The Merck Index, 13th edn, Merck, Whitehouse Station, New Jersey, 2001, pp. 1335, 1061
-  P. Venkatesh, T. Harisudhan, H. Choudhury, R. Mullangi, and N.R. Srinivas, Biomed. Chromatogr., 20 (10), 1043 (2006)
-  K.D. Tripathi, Essentials of Medical Pharmacology, Jaypee Brothers Medical Publishers, New Delhi, 2003, p. 246
-  V.L. Kulkarni and P.P. Mahulikar, Res. J. Chem. Environ., 10 (1), 21 (2006)
-  P.K. Shrivastava, P.K. Bansiwal, D. Jain, and S.K. Shrivastava, Asian J. Pharm, 1 (1), 55 (2006)
-  T.C. Lalhariatpulli and N. Kawathekar, Indian Drugs, 42 (11), 740 (2005)
-  R. Bhanu, S.K. Kulkarni, and A.B. Kadam, Indian Drugs, 43 (1), 16 (2006)
-  U.D. Pawar and K.V. Mangonkar, Indian Drugs, 43 (10), 852 (2006)
-  ICH, Q2A Validation of Analytical Procedures: Consensus Guidelines; ICH Harmonized Tripartite Guidelines, 1994
-  ICH, Q2B Validation of Analytical Procedures: Methodology, Consensus Guidelines; ICH Harmonized Tripartite Guidelines, 1996
-  M. Ribani, C.H. Collins, and C.B.G. Bottoli, J. Chromatogr. A, 1156 , 201 (2007).