STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF VILDAGLIPTIN AND METFORMIN IN PHARMACEUTICAL DOSAGE FORM


Ramesh Jayaprakash, Senthil Kumar Natesan

Abstract


Objective: The present study was aimed to develop a rapid, accurate, linear, sensitive and validate stability-indicating high performance liquid chromatographic [RP-HPLC] method for determination of vildagliptin and metformin in pharmaceutical dosage form.

Methods: The chromatographic separation was performed on kromasil-C18 column [4.5 x 250 mm; 5 µm] using a mobile phase consisting of 0.05 mmol potassium dihydrogen phosphate buffer: acetonitrile [80:20 v/v], [pH adjusted to 3.5 using orthophosphoric acid]. The flow rate is 0.9 ml/min and the detection was carried out at 263 nm.

Results: The chromatographic condition, the peak retention time of metformin and vildagliptin were found to be 2.215 min and 2.600 min respectively. Stress testing was performed in accordance with an international conference on harmonization [ICH] Q1A R2 guidelines. The method was validated as per ICH Q2 R1 guidelines. The calibration curve was found to be linear in the concentration range of 5-17.5 µg/ml and 50-175 µg/ml for vildagliptin and metformin. The limit of detection and quantification was found to be 0.0182 µg/ml and 0.0553 µg/ml for vildagliptin and 0.4451 µg/ml and 1.3490 µg/ml for metformin respectively.

Conclusion: A new sensitive, simple and stability indicating reverse-phase high-performance liquid chromatography [RP-HPLC] method has been developed and validated for the determination of vildagliptin and metformin. The proposed method can be used for routine determination of vildagliptin and metformin.


Keywords


Metformin, Method validation, RP-HPLC, Stability indicating method, Vildagliptin

References


McIntosh CH, Demuth HU, Pospisilik JA, Pederson R. Dipeptidyl peptidase IV inhibitors. How do they work as new antidiabetic agents. Regul Pept 2005;128:159-65.

Webwr AE. Dipeptidyl peptidase IV inhibitors for the treatment of diabetes. J Med Chem 2004;47:4135-41.

Lauster CD, McKaveney TP, Muench SV. Levabuterol: a novel oral therapy for type 2 diabetes mellitus. Am J Health Syst Pharm 2007;64:1265-73.

Handan HE, PhiTran, Hequn Yin, Harold Smith, Yannick Batard, Lai Wang, et al. Absorption metabolism and excretion of vildagliptin, a novel dipeptidyl peptidase-4 inhibitor, in humans. Drug Metab Dispos 2009;37:536-44.

Cai LI Z, Jian Jie J, Yan Na W, Feng Rui Y, Jun Qui S, Jian Shi L. Study on pharmacokinetics and bioavailability of metformin Hcl sustained release tablet in healthy chinese volunteers. Asian J Pharmacodynamics Pharmacokinetics 2010;10:221-8.

Obaid A, Roohi O, Syed WH. Hypoglycemic potential of tablet metformin 500 mg (GlucophageandMetaphage): a pharmacological endpoint evaluation. Pak J Pharm Sci 2003; 6:29-41.

Mohammed Ishaq B, Vanitha Prakash K, Krishna Mohan G. RP-HPLC method for simultaneous estimation of metformin and vildagliptin in bulk and its tablet formulation. J Globle Tren Pharm Sci 2012;3:747-54.

Subhakar Nandipati, Krishna Reddy V, Ravindranadh Reddy T. Development and validation of a RP-HPLC method for simultaneous determination of vildagliptin and metformin in bulk and formulation dosage form. Int Res J Pharm Appl Sci 2012;2:44-50.

Santhosha B, Ravindranath A, Sundari Ch. Validated method for the simultaneous estimation of metformin hydrochloride and vildagliptin by RP-HPLC in bulk and the pharmaceutical dosage form. Int Res J Pharm Appl Sci 2012;2:22-8.

Mohammad Yunoos, Gowri Sankar D. A validated a stability-indicating high-performance liquid chromatographic method for simultaneous determination of metformin Hcl and dapagliflozin in bulk drug and tablet dosage form. Asian J Pharm Clin Res 2015;3:320-6.

Shrikrishna B Baokar, Sugandha V Mulgund, Nisharani S Ranpise. Development and validation of RP-HPLC method for simultaneous estimation of vildagliptin and metformin. Res J Pharm Dos Forms Technol 2013;5:95-8.

PSR CH, NP Varme D, Lakshmana Rao A, Dinda SC. Simultaneous determination of metformin and vildagliptin in solid dosage form by a stability indicating RP-HPLC method. Int Res J Pharm 2013;4:122-8.

Gattu Madhava Prathap, Muthukumaran M, Krishnamoorthy B. Development and validation of simultaneous estimation of vildagliptin and metformin hydrochloride by RP-HPLC in bulk and oral dosage form. Int J Adv Pharm Gen Res 2014;2:24-33.

Usharani Gundala, Chandra Shekar Bhuvanagiri, Devanna nayakanti. Simultaneous estimation of vildagliptin and metformin hydrochloride in bulk and pharmaceutical dosage form by RP-HPLC. Indo Am J Pharm Res 2013;3:1554-63.

Aparajita Malakar, Bishwajit Bokshi, Dilruba Nasrin. Development and validation of a RP-HPLC method for estimation of vildagliptin from tablet dosage form. Int J Pharma Life Sci 2012;1:1-8.

Hanumantha Rao K, Lakshmana Rao A, Chandra Sekhar KB. Development and validation of HPLC method for the estimation of vildagliptin in pharmaceutical dosage form. Int J Pharm Chem Biol Sci 2014;4:361-6.

International conference on harmonization tripartite guideline on stability testing of new drug substances and products text and methodology: Q1A (R2); 2003.

International conference on harmonization tripartite guideline on validation of analytical procedures text and methodology: Q1B; 2005.

International conference on harmonization tripartite guideline on validation of analytical procedures text and methodology: Q2 (R1); 2005.



About this article

Title

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF VILDAGLIPTIN AND METFORMIN IN PHARMACEUTICAL DOSAGE FORM

Keywords

Metformin, Method validation, RP-HPLC, Stability indicating method, Vildagliptin

DOI

10.22159/ijpps.2017v9i3.16233

Date

03-02-2017

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 9, Issue 3, 2017 Page: 150-157

Online ISSN

0975-1491

Statistics

46 Views | 84 Downloads

Authors & Affiliations

Ramesh Jayaprakash
Department of Pharmaceutical Analysis, JKK Munirajah Medical Research Foundation’s- Annai JKK Sampoorani Ammal College of Pharmacy, Komarapalayam, Namakkal -DT, Tamilnadu, India
India

Senthil Kumar Natesan
Department of Pharmaceutical Analysis, JKK Munirajah Medical Research Foundation’s- Annai JKK Sampoorani Ammal College of Pharmacy, Komarapalayam, Namakkal -DT, Tamilnadu, India

 

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