A A VALIDATED REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-CHARGED AEROSOL DETECTOR TECHNIQUE FOR THE SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND ERTUGLIFLOZIN IN PURE AND PHARMACEUTICAL DOSAGE FORMS

ANJANEYULU REDDY B; RADHAKRISHNANAND P; IRSHAD ALAM MD; RAVI KIRAN P

doi:10.22159/ajpcr.2019.v12i5.32604

Authors

ANJANEYULU REDDY B Department of , Faculty of Science, Pacific Academy of Higher Education and Research University, Udaipur, Rajasthan, India.
RADHAKRISHNANAND P Department of , Daicel Chiral Technologies, Hyderabad, Telangana, India.
IRSHAD ALAM MD Department of , Faculty of Science and Technology, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, Maharashtra, India.
RAVI KIRAN P Department of Chemistry, BITS-Pilani, Medchal, Telangana, India.

DOI:

https://doi.org/10.22159/ajpcr.2019.v12i5.32604

Keywords:

Ertugliflozin, Sitagliptin, Diabetes mellitus, RP-HPLC-CAD, Linearity and Validation

Abstract

Objective: The main objective of the present work is to develop and validate a selective reverse-phase (RP) high-performance liquid (HPLC)-charged aerosol detection technique for the quantitation of the sitagliptin and ertugliflozin in dosage form to attain high degree of sensitivity.

Materials and Methods: In present HPLC technique, separation of drugs was achieved on Phenomenex C18 column (250×4.6 mm, 5 μ) with a mobile phase composition of phosphate buffer (pH – 5.8), acetonitrile, and methanol in the proportion of 40:40:20%V/V. 1 ml/min flow rate and 256 nm wavelength detection were maintained for the elution of drugs in the chromatographic system. The retaining time of sitagliptin and ertugliflozin in column was found to be 4.2 and 2.4 min, respectively.

Results: The projected technique was successfully applied for the quantitation of sitagliptin and ertugliflozin as a single combined mixture. The linearity statistics for calibration curves shown a good linearity in the concentration range of 0.3125–10 μg/ml for sitagliptin and 0.0625–2.5 μg/ml for ertugliflozin. The average values of regression coefficient, slope, and intercept were 0.9998, 8688.2, and 1977.6 for sitagliptin and 0.9996, 33602, and 1852.6 for ertugliflozin. The technique was validated as per the International Council for Harmonization guidelines. The limit of detection and limit of quantification findings were 0.082 and 0.247 μg/ml for sitagliptin and 0.04 and 0.12 μg/ml for ertugliflozin.

Conclusion: The developed and validated RP-HPLC-charged aerosol detector technique of sitagliptin and ertugliflozin in dosage form showed that the method was accurate and selective with high degree of sensitivity.

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References

Gallwitz B. Sitagliptin: Profile of a novel DPP-4 inhibitor for the treatment of Type 2 diabetes. Drugs Today (Barc) 2007;43:13-25.

American Diabetes Association. Standards of medical care for patients with diabetes mellitus (Position Statement). Diabetes care 2003;26 Suppl 1:S33-50.

Goodarzi MO, Breyer-Ash M. Ertugliflozin revisited: Re-evaluation of its properties and role in the pharmacopeia of modern antidiabetic agents. Diabetes Obes Metab 2005;7:654-65.

Pritam J, Amar C, Bhargav D, Shani P, Santsaran P, Hiren S. Development and validation of first order derivative UV-spectrophotometric method for determination of sitagliptin in bulk and in formulation. Int J Drug Dev Res 2011;3:194-9.

Barnard K, Cox ME, Green JB. Clinical utility of fixed combinations of sitagliptin-metformin in treatment of Type 2 diabetes. Diabetes Metab Syndr Obes 2010;3:363-72.

O’Neil MJ, Heckelman PE, Koch CB, Roman KJ. The Merk Index: An Encyclopedia of Chemicals, Drugs and Biologicals. 14th ed. Whitehouse Station NJ, USA: Merk and Co, Inc.; 2012.

AbuRuz S, Millership J, McElnay J. Determination of metformin in plasma using a new ion pair solid phase extraction technique and ion pair liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci 2003;798:203-9.

Zarghi A, Foroutan SM, Shafaati A, Khoddam A. Rapid determination of metformin in human plasma using ion-pair HPLC. J Pharm Biomed Anal 2003;31:197-200.

Koseki N, Kawashita H, Niina M, Nagae Y, Masuda N. Development and validation for high selective quantitative determination of metformin in human plasma by cation exchanging with normal-phase LC/MS/MS. J Pharm Biomed Anal 2005;36:1063-72.

Wang Y, Tang Y, Gu J, Fawcett JP, Bai X. Rapid and sensitive liquid chromatography-tandem mass spectrometric method for the quantitation of metformin in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2004;808:215-9.

Vehovec T, Obreza A. Review of operating principle and applications of the charged aerosol detector. J Chromatogr A 2010;1217:1549-56.

Soliven A, Haidar Ahmad IA, Tam J, Kadrichu N, Challoner P, Markovich R, et al. A simplified guide for charged aerosol detection of non-chromophoric compounds-analytical method development and validation for the HPLC assay of aerosol particle size distribution for amikacin. J Pharm Biomed Anal 2017;143:68-76.

Ligor M, Studzińska S, Horna A, Buszewski B. Corona charged aerosol detection: An analytical approach. Crit Rev Anal Chem 2013;43:64-78.

Ragham PK, Kothapalli BC. Development and validation of a stability-indicating RP-HPL C-CAD method for gabapentin and its related impurities in presence of degradation products. J Pharm Biomed Anal 2016;125:122-9.

Hamdana H, BaniJaber AK, Abushoffa AM. Development and validation of a stability indicating capillary electrophoresis method for the determination of ertugliflozin hydrochloride in tablets. J Pharm Biomed Anal 2010;53:1254-7.

Zhai H, Wu Y, Huang B, Huang Q, Yang B, Chen Z. Rapid determination of ertugliflozin hydrochloride in ertugliflozin hydrochloride tablets by capillary electrophoresis. Huaxne Yanjiu Yu Yingvong 2008;20:923-6.

Polagani SR, Pilli NR, Gagula R, Gandu V. Simultaneous determination of atorvastatin, ertugliflozin and glimpiride in human plasma by LC-MS/MS and its application to human pharmacokinetic study. J Pharm Anal 2013;3:9-19.

Pathade P, Imran M, Bairagi V, Ahire Y. Development and validation stability indicating UV spectrophotometric method for the estimation of sitagliptin phosphate in bulk and tablet dosage form. J Pharm Res 2011;4:871-3.

Reddy BV, Raman N, Kumar BS, Rambabu C. Chiral separation of sitagliptin phosphate enantiomer by HPLC using amylose based chiral stationary phase. J Pharm Res 2013;7:46-50.

Jiu X-F, Shang D, Chen Y, Wang Y, Huang L, Peng D, et al. A high performance liquid chromatography method for quantitative determination assay of sitagliptin in rat plasma and its application in pharmacokinetic study. J Chin Pharm Sci 2011;20:63-9.

Bodar JD, Kumar S, Yadav YC, Sahoo U. Development of the spectrophotometric method for the simultaneous estimation of pioglitazone and ertugliflozin. Int J Pharm Sci 2011;2:236-43.

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. Indo Am J Pharm Sci 2018;5:2616-27.

Suneethaa A, Kathirvela S, Ramachandrika G. A validated RP-HPLC method for simultaneous estimation of lopinavir and ritonavir in combined dosage form. Int J Pharm Pharm Sci 2011;3:49-51.

Nashwahgadallah M. Validated HPLC method for simultaneous determination of sitagliptin, metformine and atorvastatin in pure form and in pharmaceutical formulations. Int J Pharm Pharm Sci 2014; 5:665 70.

Brahmaiah B, Sujana K, Rani AP. Development and validation of RP-HPLC method for simultaneous determination of ramipril and valsartan in bulk and pharmaceutical dosage forms. Asian J Pharm Clin Res 2012;6:23-5.

Abdel-Ghany MF, Abdel-Aziz O, Ayad MF, Tadros MM. Validation of different spectrophotometric methods for determination of vildagliptin and metformin in binary mixture. Spectrochim Acta A Mol Biomol Spectrosc 2014;125:175-82.

Mohd M, Rahaman SA, Yadav BR, Battu R. Development and validation of a reverse phase HPLC method for simultaneous estimation of rosuvastatin calcium and fenofibrate in tablet dosage form. Int J Pharm Pharm Sci 2011;4:150-4.

Charde MS, Welankiwar AS, Chakole RD. Development of validated RP-HPLC method for the simultaneous estimation of atenolol and chlorthalidone in combine tablet dosage form. Int J Adv Pharm 2014;3:6-18.

Aburuz S, Millership J, McElnay J. The development and validation of liquid chromatography method for the simultaneous determination of metformin and glipizide, gliclazide, glibenclamide or glimperide in plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2005; 817:277 86.

Validation of Analytical Procedure, Text and Methodolgy. International Conference on Harmonisation ICH Q2 (R1); 2005.