Development and Validation of a Method for Simultaneous Determination of Metformin Hydrochloride and Sitagliptin Phosphate in a Formulation by RP-HPLC
Read full paper at:
http://www.scirp.org/journal/PaperInformation.aspx?PaperID=48944#.VJjZRcCAM4
http://www.scirp.org/journal/PaperInformation.aspx?PaperID=48944#.VJjZRcCAM4
Author(s)
Present study was aimed to develop and validate a
reverse-phase high-performance liquid chromatography method for
simultaneous determination of sitagliptin phosphate and metformin
hy-drochloride in a marketed formulation. The drug separation was
performed on Hibar-240, Li-chrosphere-100 C18 ODS (250 × 4.6 mm, 5 μm)
column, at a flow rate of 1 mL/min. The mobile phase used was a mixture
of methanol: potassium di-hydrogen phosphate buffer at a ratio of 70:30
v/v. The detection was carried out at a wavelength of 266 nm. The
retention times of sitagliptin phosphate and metformin hydrochloride
were found as 6.1 and 4.9 min respectively. Linear calibration curves
with good correlation coefficients were obtained over the concentration
ranges of 10 - 50 μg/mL for sitagliptin and 20 - 100 μg/mL for
metformin. The limit of detection was 0.016 and 0.14 μg/mL and the limit
of quantification was 0.048 and 0.42 μg/mL for sitagliptin phosphate
and metformin hydrochloride respectively. Validation of the method
demonstrated system selectivity, specificity, linearity, accuracy and
precision. The developed method was found useful in the simultaneous
analysis of sitagliptin phosphate and metformin hydrochloride in
formulation.
KEYWORDS
Cite this paper
Prasad, P. , Satyanarayana, K. and Krishnamohan, G.
(2014) Development and Validation of a Method for Simultaneous
Determination of Metformin Hydrochloride and Sitagliptin Phosphate in a
Formulation by RP-HPLC. American Journal of Analytical Chemistry, 5, 737-742. doi: 10.4236/ajac.2014.511082.
| [1] |
Rao, R.N., Maurya, P.K. and
Khalid, S. (2011) Development of a Molecularly Imprinted Polymer for
Selective Extraction Followed by Liquid Chromatographic Determination of
Sitagliptin in Rat Plasmaand Urine. Talanta, 85, 950-957. http://dx.doi.org/10.1016/j.talanta.2011.05.002 |
| [2] |
Sengupta, P., Bhaumik, U.,
Ghosh, A., Sarkar, A.K., Chatterjee, B., Bose, A. and Pal, T.K. (2009)
LC-MS-MS Development and Validation for Simultaneous Quantitation of
Metformin, Glimepiride and Pioglitazone in Human Plasma and Its
Application to a Bioequivalence Study. Chromatographia, 69, 1243. http://dx.doi.org/10.1365/s10337-009-1056-5 |
| [3] |
Herman, G.A., Bergman, A.,
Stevens, C., Kotey, P., Yi, B., Zhao, P., et al. (2006) Effect of Single
Oral Doses of Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, on
Incretin and Plasma Glucose Levels after an Oral Glucose Tolerance Test
in Patients with Type 2 Diabetes. The Journal of Clinical Endocrinology
and Metabolism, 91, 4612-4619. http://dx.doi.org/10.1210/jc.2006-1009 |
| [4] |
Herman, G.A., Stevens, C., Van
Dyck, K., Bergman, A., Yi, B., De Smet, M., et al. (2005)
Pharmacokinetics and Pharmacodynamics of Sitagliptin, an Inhibitor of
Dipeptidyl Peptidase IV, in Healthy Subjects: Results from Two
Randomized, Double-Blind, Placebo-Controlled Studies with Single Oral
Doses. Clinical Pharmacology and Therapeutics, 78, 675-688. http://dx.doi.org/10.1016/j.clpt.2005.09.002 |
| [5] |
El-Bagary, R.I., Elkady, E.F.
and Ayoub, B.M. (2011) Liquid Chromatographic Determination of
Sitagliptin either Alone or in Ternary Mixture with Metformin and
Sitagliptin Degradation Product. Talanta, 85, 673-680. http://dx.doi.org/10.1016/j.talanta.2011.04.051 |
| [6] |
Fonseca, V., Staels, B., Morgan
II, J.D., Shentu, Y., Golm, G.T., Johnson-Levonas, A.O., Kaufman, K.D.,
Goldstein, B.J. and Steinberg, H. (2013) Efficacy and Safety of
Sitagliptin Added to Ongoing Metformin and Pioglitazone Combination
Therapy in a Randomized, Placebo-Controlled, 26-Week Trial in Patients
with Type 2 Diabetes. Journal of Diabetes and Its Complications, 27,
177-183. http://dx.doi.org/10.1016/j.jdiacomp.2012.09.007 |
| [7] |
American Diabetes Association
(2012) Standards of Medical Care in Diabetes—2012. Diabetes Care, 35,
S11-S63. http://dx.doi.org/10.2337/dc12-s011 |
| [8] | Salsali, A. and Pratley, R. (2007) Does Addition of Sitagliptin to Metformin Monotherapy Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus. Nature Reviews Endocrinology, 3, 450. |
| [9] |
Liu, A. and Coleman, S.P. (2009)
Determination of Metformin in Human Plasma Using Hydrophilic
Interaction Liquid Chromatography-Tandem Mass Spectrometry. Journal of
Chromatography B, 877, 3695-3700. http://dx.doi.org/10.1016/j.jchromb.2009.09.020 eww141223lx |
| [10] | The ICH Steering Committee (1996) Harmonized Triplicate Guideline on Validation of Analytical Procedures: Methodology, Recommended for Adoption at Step 4 of the ICH Process. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceutical for Human Use, November 1996, IFPMA, Switzerland. |
评论
发表评论