DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND ERTUGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Authors

  • Venkateswara Rao P Department of Pharmacy, JNTUK University, Kakinada, Vikas College of Pharmacy, Vissanapeta, Andhra Pradesh, India.
  • Lakshmana Rao A Department of Pharmacy, V. V. Institute of Pharmaceutical Sciences, Gudlavalleru, Andhra Pradesh, India.
  • Prasad Svum Department of Pharmacy, School of Pharmacy, JNTUK University, Kakinada, Andhra Pradesh, India.

DOI:

https://doi.org/10.22159/ajpcr.2019.v12i1.28938

Keywords:

Metformin hydrochloride, Ertugliflozin, Reversed-phase - high-performance liquid chromatography, Validation, Simultaneous, Degradation

Abstract

Objective: The present study deals with the development, validation, and application of simple, precise, and accurate high-performance liquid chromatography (HPLC) method for the simultaneous estimation of metformin hydrochloride and ertugliflozin in pharmaceutical formulation and to validate.

Methods: The analytical conditions were optimized on BDS C8 column (150 mm × 4.6 mm, 5 μm) at room temperature. The mobile phase consists of buffer: acetonitrile in 55:45 v/v ratio. Injection volume was 10 μl. The flow rate was maintained at 1.0 ml/min, and the analysis was carried out at 224 nm.

Results: The method was found to be linear in the concentration range of 125–750 μg/ml and 1.875–11.25 μg/ml for metformin hydrochloride and ertugliflozin with regression coefficient r2 = 0.999. The method was found to be precise with percentage relative standard deviation below 2%. The limit of detection and limit of quantification were found to be within the limits. The percentage recovery of the developed method was 100.15%. All the validation parameters such as robustness, recovery, and precision were found to be within the limits. Degradation parameters such as acid, base, thermal and peroxide, light, temperature, and humidity were performed and found that the drugs are stable in all the extreme conditions.

Conclusions: A simple, accurate, precise, and less time-consuming reversed-phase HPLC method for the simultaneous estimation of metformin hydrochloride and ertugliflozin has been developed and validated in accordance with the ICH guidelines.

Downloads

Download data is not yet available.

Author Biography

Venkateswara Rao P, Department of Pharmacy, JNTUK University, Kakinada, Vikas College of Pharmacy, Vissanapeta, Andhra Pradesh, India.

Pharmaceuitical Analysis

References

Merck and Co., Inc: STEGLATRO (Ertugliflozin) Tablets, for Oral use Initial U.S. Approval. Kenilworth New Jersey: Merck and Co Inc.; 2017. p. 1-23.

Ertugliflozin and Metformin Hydrochloride: Drug description. Available from: http://www.rxlist.com/segluromet-drug. [Last reviewed on 2017 Dec 28]; [Last accessed on 2018 Apr 12].

Drug Profile for Metformin Hydrochloride. Available from: http://www. pubchem.drugbank.ca/metforminhydrochloridePubchemCID14219. [Last accessed on 2018 Apr 12].

Drug Profile for Ertugliflozin. Available from: https://www.drugbank. ca/drugs/DB11827. [Last accessed on 2018 Jan 12].

Drug Profile for Ertugliflozin. Available from: https://www.pubchem. ncbi.nlm.nih.gov/compound/Ertugliflozin.PubChemCID:44814423. [Last accessed on 2018 Apr 12].

Karimulla SK, Vasanth PM, Ramesh T, Ramesh M. Method development and validation of sitagliptin and metformin using reverse phase HPLC method in bulk and tablet dosage form. Pharm Lett 2013;5:168-74.

Hendy M. Improved chromatographic separation of sitagliptin phosphate and metformin hydrochloride. Int J Biomed Sci 2015;2:190-4.

Ashutosh S, Manidipa D, Rao NS. Development of stability indicating RP-HPLC method for simultaneous estimation of metformin hydrochloride and sitagliptin phosphate monohydrate in bulk as well as in pharmaceutical formulation. Pharm Sin 2013;4:47-61.

Murthy TG, Geethanjali J. Development of a validated RP-HPLC method for simultaneous estimation of metformin hydrochloride and rosuvastatin calcium in bulk and in-house formulation. J Chromatogr Tech 2015;5:252-6.

Arshiya S, Jagirdar S. Analytical method development and validation for the determination of sitagliptin and metformin using RP-HPLC method in bulk and tablet dosage form. J Bioanal Biomed 2014;6:120-12.

Inamdar HP, Ashok A. RP-HPLC method for simultaneous determination of metformin hydrochloride, rosiglitazone and sitagliptin-application to commercially available drug products. Int J Pharm Sci Res 2012;3:3267-76.

Ramesh J, Kumar NS. Stability indicating RP-HPLC method development and validation for the simultaneous determination of vildagliptin and metformin in pharmaceutical dosage form. Int J Pharm Pharm Sci 2017;9:150-7.

Srivani J, Umamahesh B, Veeresham C. Development and validation of stability indicating HPTLC method for simultaneous determination of linagliptin and metformin. Int J Pharm Pharm Sci 2016;8:112-5.

Neelima K, Prasad YR, Prasad N. Analytical method development and validation of metformin, voglibose, glimepiride in bulk and combined tablet dosage form by gradient RP-HPLC. Pharm Methods 2014;5:186-91.

Prasanthi CH, Parameswari SA, Aruna G. Development and validation of RP-HPLC method for metformin hydrochloride and nateglinide in bulk and combined dosage form. Int J Pharm Pharm Sci 2016;8:267-71.

Rao PV, Rao AL, Prasad SV. A new stability indicating Rp-Hplc method for simultaneous estimation of ertugliflozin and sitagliptin in bulk and pharmaceutical dosage form its validation as Per ICH guidelines if there are images in this attachment, they will not be displayed. Download the original attachment. Indo Am J Pharm Sci 2018;5:520-9.

ICH. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of analytical procedure: Text and Methodology Q2 (R1); 2005.

ICH. Validation of Analytical Procedures: Text and Methodology. Geneva: International Conference on Harmonization, IFPMA; 1996.

ICH. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Stability Testing of New Drug Substances and Products Q1B (R2); 1997.

Published

07-01-2019

How to Cite

Rao P, V., L. Rao A, and P. Svum. “DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND ERTUGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM”. Asian Journal of Pharmaceutical and Clinical Research, vol. 12, no. 1, Jan. 2019, pp. 235-40, doi:10.22159/ajpcr.2019.v12i1.28938.

Issue

Section

Original Article(s)