MODIFIED QUANTIFICATION THROUGH HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY ANALYSIS FOR CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE IN BULK AND TABLETS USING ECOFRIENDLY GREEN SOLVENTS


Aditya Trivedi, Noopur Dixit, D. N. Jhade

Abstract


Objective: An accurate, precise, specific modified High-Performance Liquid Chromatography method was developed for the simultaneous quantification of canagliflozin and metformin in bulk and dosage forms.

Methods: A C18 column (250 x 4.6 mm; 5 µm Phenomenex) was used with mobile phase containing 0.05% v/v triethylamine (pH 6.5): acetonitrile (45:55% v/v) at 20 °C and isocratic pump was used for elution. The flow rate was maintained at 1.2 ml/min and eluents were monitored at 215 nm which is evaluated by sharp peak.

Results: The retention times of canagliflozin and metformin were 3.4 min and 12.7 min respectively and showed a good linearity in the concentration range of 40-200 µg/ml of Canagliflozin have found a correlation coefficient of 0.999 and 10-50 µg/ml of Metformin with a correlation coefficient of 0.998. The average percent recoveries were found to be 98.60% and 98.90% respectively for Canagliflozin and Metformin. The developed method follows all the validation parameters like accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability.

Conclusion: The proposed method was found to provide faster retention time with sharp resolution with linearity at a lowest concentration as compared to previous methods and this method is validated as per International Conference on Harmonization guidelines and successfully applied to the simultaneous estimation of Canagliflozin and metformin in bulk and dosage forms. There was no such novel method for simultaneous estimation of Canagliflozin and metformin. Hence the developed method is suitable for industrial analysis of Canagliflozin and metformin with eco-friendly,green and less expensive solvents


Keywords


Canagliflozin, Metformin, Simultaneous estimation, Phenomenex C18 column, RP-HPLC, PDA detection, Validation

| PDF | HTML |

References


Schernthaner G, Gross JL, Rosenstock J, Guarisco M, Fu M, Yee J, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea. Diabetes Care 2013; 36:2508-15.

Ningrum VDA, Ikawati Z, Sadewa AH, Ikhsan MR, Saepudin S. Steady-state pharmacokinetics of metformin in obese patients with type 2 diabetes mellitus: a preliminary study. Asian J Phrm Clini Res 2017;10:294-8.

Nisly Sarah A, Denise M, K Alison MW. Canagliflozin, a new sodium-glucose cotransporter 2 inhibitor, in the treatment of diabetes. Am J Health Syst Pharm 2013;70:311-9.

Madana Gopal N, Sridhar C. A validated stability indicating a ultra-performance liquid chromatographic method for simultaneous determination of metformin hydrochloride and empagliflozin in bulk drug and tablet dosage form. Int J Appl Pharm 2017;9:45-50.

Wiernsperger NF, Clifford JB. The antihyperglycemic effect of metformin. Drugs 1999;58 Suppl 1:31-9.

Khasim Sharif Sd, Radha Sirija M, Ramudu B, Ramachandran D. Green synthesis of tetrahydropyranyl ethers of phenols in the presence of triethylamine in water as a solvent. IORS J Appl Chem 2015;8:20-5.

(a) Ibrahim F, Asmaa Kamal, El-Deen Samah, Abo El Abass, Kuniyoshi Shimizu. An eco-friendly green liquid chromatographic method for simultaneous determination of nicotinamide and clindamycin phosphate in the pharmaceutical gel for acne treatment. J Food Drug Anal 2016. http://dx.doi.org/10.1016/j.jfda.2016.09.009

International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use Validation of analytical procedure: Methodology. ICH Q2(R1). Geneva 1996;4:1-10.

Suneetha D, Sharmila A. Validated stability indicating a RP-HPLC method for estimation of canagliflozin in the dosage form. Res J Pharm Biol Chem Sci 2015;6:1186-94.

Ishpreet K, Sharad W, Harsharan PS, Satish M. Development and validation of a stability-indicating reverse phase HPLC-PDA method for determination of canagliflozin in bulk and pharmaceutical dosage form. Pharm Methods 2016;7:54-62.

Snyder LR, Joseph JK, Joseph LG, Practical HPLC method development. John Wiley Sons 2012;2:42-9.

Shabir GA. Validation of high-performance liquid chromatography methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the US food and drug administration, the US pharmacopeia and the International Conference on Harmonization. J Chrom A 2003;987:57-66.

Chandran S, Singh RSP. Comparison of various international guidelines for analytical method validation. Die Pharmazie Int J Pharm Sci 2007;62:4-14.




About this article

Title

MODIFIED QUANTIFICATION THROUGH HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY ANALYSIS FOR CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE IN BULK AND TABLETS USING ECOFRIENDLY GREEN SOLVENTS

Keywords

Canagliflozin, Metformin, Simultaneous estimation, Phenomenex C18 column, RP-HPLC, PDA detection, Validation

DOI

10.22159/ijap.2017v9i5.20112

Date

15-09-2017

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 9, Issue 5 (Aug-Sep), 2017 Page: 97-101

Online ISSN

0975-7058

Statistics

0 Views | 0 Downloads

Authors & Affiliations

Aditya Trivedi
Sri Satya Sai University of Technology & Medical Sciences, Opposite Sehore (M.P.) India
India

Noopur Dixit
Siddhi Vinayaka Institute of Technology and Sciences Bilaspur C.G.
India

D. N. Jhade
Sri Satya Sai University of Technology & Medical Sciences, Opposite Sehore (M.P.) India
India


Refbacks

  • There are currently no refbacks.