Ravi Pratap Pulla, B.S. Sastry, Y. Rajendra Prasad, N. Appala Raju
Ravi Pratap Pulla1, B.S. Sastry2, Y. Rajendra Prasad3 and N. Appala Raju4
1Department of Pharmaceutical Chemistry, SSJ College of Pharmacy, V.N. Pally, Gandipet, Hyderabad-500 075.
2Department of Pharmaceutical Chemistry, Principal and Professor, Medak Institute of Technology-Pharmacy, Kothapet (V), Near Narsapur, Shivampet, Medak District- 502 334.
3Department of Pharmaceutical Chemistry, Associate Professor, Andhra University – College of Pharmaceutical Sciences, Peda Waltair, Visakhapatnam- 530 003.
4Department of Pharmaceutical Chemistry, Sultan-Ul-Uloom College of Pharmacy, Mount Pleasant, Road No# 3, Banjara Hills, Hyderabad-500 034.
Volume - 4,
Issue - 4,
Year - 2011
A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Metformin HCl and Sitagliptin PO4 in tablet dosage forms. An Xterra C18, 250x4.6 mm, column with 5 µm particle size and the mobile phase consisting of 0.03M K2HPO4 in water pH-3.2 adjusted with o-Phosphoric Acid: Acetonitrile in the gradient mode was used. The flow rate was 1.0 ml/min and the effluents were monitored at 207 nm. The retention times were 2.510 min for Metformin HCl and 7.673 min for Sitagliptin PO4. The detector response was linear in the concentration of 14-168 mcg/mL for Metformin HCl and 1.3-15.6 mcg/mL for Sitagliptin PO4. The respective linear regression equation being Y= 48822.5x+10329 for Sitagliptin PO4 and Y= 70435x+238894 for Metformin HCl. The Limit of Detection (LOD) is 0.13 mcg and 0.14 mcg for Sitagliptin PO4 and Metformin HCl respectively. The Limit of Quantification (LOQ) is 0.39 mcg for Sitagliptin PO4 and 0.42 mcg for Metformin HCl. The percentage assay of Metformin HCl and Sitagliptin PO4 was 99.46 % and 99.19% respectively. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Metformin HCl and Sitagliptin PO4 in bulk drug and in its pharmaceutical dosage forms.
Cite this article:
Ravi Pratap Pulla, B.S. Sastry, Y. Rajendra Prasad, N. Appala Raju. Simultaneous Estimation of Metformin HCL and Sitagliptin Phosphate in Tablet Dosage Forms by RP-HPLC. Research J. Pharm. and Tech. 4(4): April 2011; page 646-649.