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Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination

Yıl 2023, Cilt: 27 Sayı: 3, 1234 - 1241, 28.06.2025

Nayeem Khan Majaz Qazi Yaasir Ahmed Ansari Afsar Shaikh Ayyaj A. Badgire Mohd Salman Noosrat Jahan Khan

Öz

A new HPLC method has been developed and validated with different parameters for the estimation of
Canagliflozin and Metformin in Fixed-Dose Combination. The chromatograms were developed using a mobile phase
of Methanol: 0.1 % OPA in water (35:65) with a flow rate of 0.7 ml/min. C18 Column of 4.6 x 100 mm dimension was
used as a stationary phase, particle size 5µm. The detection was carried out at 245 nm. The method was validated
according to ICH guidelines for linearity, precision and Repeatability, Robustness, LOD, and LOQ. The response was
found to be linear in a concentration range of 100-500 µg/ml for Metformin and 10-50 µg/mL for Canagliflozin. The
stability studies of Metformin and Canagliflozin were also done through the exposure of analyte solution to different
stress conditions. The developed HPLC method of Metformin and Canagliflozin was simple, precise, accurate,
reproducible, and therefore suitable for routine analysis of drugs in a dosage form

Anahtar Kelimeler

HPLC Method Development Method Validation Forced degradation Canagliflozin Metformin.

Kaynakça

  • [1] Raut AN, Jawarkar SG, Khodke VS, Khole VA. Method development, validation by simultaneous estimation of empagliflozin and linagliptin by RP-HPLC method. J Pharm Sci Innov. 2020; 9(1): 1–4. https://doi.org/10.7897/2277-4572.091160.
  • [2] Anjali M, Mannaz, Shreshta MR, Prasanna, Shrisha SK. Method development and validation of ertugliflozin and sitagliptin by using simultaneous equation method. J Innov Pharm Sci. 2019; 3(1): 22–28.
  • [3] Attimarad M, Elgorashe REE, Subramaniam R, Islam MM, Venugopala KN, Nagaraja S, Balgoname AA. Development and validation of rapid RP-HPLC and green second-derivative UV spectroscopic methods for simultaneous quantification of metformin and remogliflozin in formulation using experimental design. Separations. 2020; 7(4): 59. https://doi.org/10.3390/separations7040059.
  • [4] Jabbour S, Ziring B. Advantages of extended-release metformin in patients with type 2 diabetes mellitus. Postgrad Med. 2011; 123(1): 15–23. https://doi.org/10.3810/pgm.2011.01.2241.
  • [5] Attimarad M, Nagaraja SH, Aldhubaib BE, Nair A, Venugopala KN. Simultaneous determination of metformin and three gliptins in pharmaceutical formulations using RP-HPLC: Application to stability studies on linagliptin tablet formulation. Indian J Pharm Educ Res. 2014; 48(4): 45–53. http://dx.doi.org/10.5530/ijper.48.4.7.
  • [6] Sami W, Ansari T, Butt NS, Hamid MRA. Effect of diet on type 2 diabetes mellitus: A review. Int J Health Sci (Qassim). 2017; 11(2): 65–71.
  • [7] Magliano DJ, Sacre JW, Harding JL, Gregg EW, Zimmet PZ, Shaw JE. Young-onset type 2 diabetes mellitus – implications for morbidity and mortality. Nat Rev Endocrinol. 2020; 16(6): 321–331. https://doi.org/10.1038/s41574-020-0334-z.
  • [8] Alhyas L, McKay A, Balasanthiran A, Majeed A. Prevalences of overweight, obesity, hyperglycaemia, hypertension and dyslipidaemia in the Gulf: systematic review. JRSM Short Rep. 2011; 2(7): 55. https://doi.org/10.1258/shorts.2011.011019.
  • [9] Dharmalingam M, Aravind SR, Thacker H, Paramesh S, Mohan B, Chawla M, Asirvatham A, Goyal R, Shembalkar J, Balamurugan R, Kadam P, Alva H, Kodgule R, Tandon M, Vaidyanathan S, Pendse A, Gaikwad R, Katare S, Suryawanshi S, Barkate H. Efficacy and safety of remogliflozin etabonate, a new sodium glucose co-transporter-2 inhibitor, in patients with Type 2 Diabetes Mellitus: A 24-week, randomized, double-blind, active-controlled trial. Drugs. 2020; 80(6): 587–600. https://doi.org/10.1007/s40265-020-01285-0.
  • [10] Majithia RH, Khodadiya DA, Patel VB. Spectrophotometric method development and validation for simultaneous estimation of Anagliptin and Metformin HCl by Q-Absorption ratio method in synthetic mixture. Heliyon. 2020; 6(5): e03855. https://doi.org/10.1016/j.heliyon.2020.e03855.
  • [11] Attimarad MV, Nair AB, Aldhubaib BE. Development of liquid chromatographic method for the simultaneous determination of metformin and miglitol in human plasma: Application to pharmacokinetic studies. J Iranian Chem Soc. 2015; 12: 1629–1636. https://doi.org/10.1007/s13738-015-0637-5.
  • [12] Neelima K, Prasad YR. Analytical method development and validation of metformin, voglibose, glimepiride in bulk and combined tablet dosage form by gradient RP-HPLC. Pharm Methods. 2014; 5: 27–33. https://doi.org/10.5530/phm.2014.1.5.
  • [13] Gedawy A, Al-Salami H, Dass CR. Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide. J Food Drug Anal. 2019; 27: 315–322. https://doi.org/10.1016/j.jfda.2018.06.007.
  • [14] Sebaiy MM, El-Adl SM, Baraka MM, Hassan AA. Rapid RP-HPLC method for simultaneous estimation of metformin, pioglitazone, and glimepiride in human plasma. Acta Chromatogr. 2020; 32: 16–21. https://doi.org/10.1556/1326.2018.00515.
  • [15] Shirode A, Maduskar P, Deodhar M, Kadam V. RP-HPLC and HPTLC methods for simultaneous estimation of metformin hydrochloride and vildagliptin from bulk and marketed formulation: Development and validation. J Pharm Res Int. 2014; 4: 2370–2386. https://doi.org/10.9734/BJPR/2014/12820.
  • [16] Al Bratty M, Alhazmi HA, Javed SA, Lalitha KG, Asmari M, Wölker J, El Deeb S. Development and validation of LC–MS/MS method for simultaneous determination of metformin and four gliptins in human plasma. Chromatographia. 2017; 80: 891–899. https://doi.org/10.1007/s10337-017-3288-0.
  • [17] Munde MK, Kulkarni NS, Khiste RH, Sen DB. Development and validation of novel analytical method for empagliflozin and metformin hydrochloride in bulk and pharmaceutical dosage form by four different simultaneous estimation approaches using UV spectroscopy. Res J Pharm Technol. 2020; 13: 1236–1242. https://doi.org/10.5958/0974-360X.2020.00228.0.
  • [18] Mohamed D, Elshahed MS, Nasr T, Aboutaleb N, Zakaria O. Novel LC-MS/MS method for analysis of metformin and canagliflozin in human plasma: Application to a pharmacokinetic study. BMC Chem. 2019; 13: 82. https://doi.org/10.1186/s13065-019-0597-4.

Yıl 2023, Cilt: 27 Sayı: 3, 1234 - 1241, 28.06.2025

Nayeem Khan Majaz Qazi Yaasir Ahmed Ansari Afsar Shaikh Ayyaj A. Badgire Mohd Salman Noosrat Jahan Khan

Öz

Kaynakça

  • [1] Raut AN, Jawarkar SG, Khodke VS, Khole VA. Method development, validation by simultaneous estimation of empagliflozin and linagliptin by RP-HPLC method. J Pharm Sci Innov. 2020; 9(1): 1–4. https://doi.org/10.7897/2277-4572.091160.
  • [2] Anjali M, Mannaz, Shreshta MR, Prasanna, Shrisha SK. Method development and validation of ertugliflozin and sitagliptin by using simultaneous equation method. J Innov Pharm Sci. 2019; 3(1): 22–28.
  • [3] Attimarad M, Elgorashe REE, Subramaniam R, Islam MM, Venugopala KN, Nagaraja S, Balgoname AA. Development and validation of rapid RP-HPLC and green second-derivative UV spectroscopic methods for simultaneous quantification of metformin and remogliflozin in formulation using experimental design. Separations. 2020; 7(4): 59. https://doi.org/10.3390/separations7040059.
  • [4] Jabbour S, Ziring B. Advantages of extended-release metformin in patients with type 2 diabetes mellitus. Postgrad Med. 2011; 123(1): 15–23. https://doi.org/10.3810/pgm.2011.01.2241.
  • [5] Attimarad M, Nagaraja SH, Aldhubaib BE, Nair A, Venugopala KN. Simultaneous determination of metformin and three gliptins in pharmaceutical formulations using RP-HPLC: Application to stability studies on linagliptin tablet formulation. Indian J Pharm Educ Res. 2014; 48(4): 45–53. http://dx.doi.org/10.5530/ijper.48.4.7.
  • [6] Sami W, Ansari T, Butt NS, Hamid MRA. Effect of diet on type 2 diabetes mellitus: A review. Int J Health Sci (Qassim). 2017; 11(2): 65–71.
  • [7] Magliano DJ, Sacre JW, Harding JL, Gregg EW, Zimmet PZ, Shaw JE. Young-onset type 2 diabetes mellitus – implications for morbidity and mortality. Nat Rev Endocrinol. 2020; 16(6): 321–331. https://doi.org/10.1038/s41574-020-0334-z.
  • [8] Alhyas L, McKay A, Balasanthiran A, Majeed A. Prevalences of overweight, obesity, hyperglycaemia, hypertension and dyslipidaemia in the Gulf: systematic review. JRSM Short Rep. 2011; 2(7): 55. https://doi.org/10.1258/shorts.2011.011019.
  • [9] Dharmalingam M, Aravind SR, Thacker H, Paramesh S, Mohan B, Chawla M, Asirvatham A, Goyal R, Shembalkar J, Balamurugan R, Kadam P, Alva H, Kodgule R, Tandon M, Vaidyanathan S, Pendse A, Gaikwad R, Katare S, Suryawanshi S, Barkate H. Efficacy and safety of remogliflozin etabonate, a new sodium glucose co-transporter-2 inhibitor, in patients with Type 2 Diabetes Mellitus: A 24-week, randomized, double-blind, active-controlled trial. Drugs. 2020; 80(6): 587–600. https://doi.org/10.1007/s40265-020-01285-0.
  • [10] Majithia RH, Khodadiya DA, Patel VB. Spectrophotometric method development and validation for simultaneous estimation of Anagliptin and Metformin HCl by Q-Absorption ratio method in synthetic mixture. Heliyon. 2020; 6(5): e03855. https://doi.org/10.1016/j.heliyon.2020.e03855.
  • [11] Attimarad MV, Nair AB, Aldhubaib BE. Development of liquid chromatographic method for the simultaneous determination of metformin and miglitol in human plasma: Application to pharmacokinetic studies. J Iranian Chem Soc. 2015; 12: 1629–1636. https://doi.org/10.1007/s13738-015-0637-5.
  • [12] Neelima K, Prasad YR. Analytical method development and validation of metformin, voglibose, glimepiride in bulk and combined tablet dosage form by gradient RP-HPLC. Pharm Methods. 2014; 5: 27–33. https://doi.org/10.5530/phm.2014.1.5.
  • [13] Gedawy A, Al-Salami H, Dass CR. Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide. J Food Drug Anal. 2019; 27: 315–322. https://doi.org/10.1016/j.jfda.2018.06.007.
  • [14] Sebaiy MM, El-Adl SM, Baraka MM, Hassan AA. Rapid RP-HPLC method for simultaneous estimation of metformin, pioglitazone, and glimepiride in human plasma. Acta Chromatogr. 2020; 32: 16–21. https://doi.org/10.1556/1326.2018.00515.
  • [15] Shirode A, Maduskar P, Deodhar M, Kadam V. RP-HPLC and HPTLC methods for simultaneous estimation of metformin hydrochloride and vildagliptin from bulk and marketed formulation: Development and validation. J Pharm Res Int. 2014; 4: 2370–2386. https://doi.org/10.9734/BJPR/2014/12820.
  • [16] Al Bratty M, Alhazmi HA, Javed SA, Lalitha KG, Asmari M, Wölker J, El Deeb S. Development and validation of LC–MS/MS method for simultaneous determination of metformin and four gliptins in human plasma. Chromatographia. 2017; 80: 891–899. https://doi.org/10.1007/s10337-017-3288-0.
  • [17] Munde MK, Kulkarni NS, Khiste RH, Sen DB. Development and validation of novel analytical method for empagliflozin and metformin hydrochloride in bulk and pharmaceutical dosage form by four different simultaneous estimation approaches using UV spectroscopy. Res J Pharm Technol. 2020; 13: 1236–1242. https://doi.org/10.5958/0974-360X.2020.00228.0.
  • [18] Mohamed D, Elshahed MS, Nasr T, Aboutaleb N, Zakaria O. Novel LC-MS/MS method for analysis of metformin and canagliflozin in human plasma: Application to a pharmacokinetic study. BMC Chem. 2019; 13: 82. https://doi.org/10.1186/s13065-019-0597-4.
Toplam 18 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Klinik Farmakoloji ve Terapötikler
Bölüm Articles
Yazarlar

Nayeem Khan

Majaz Qazi

Yaasir Ahmed Ansari 0000-0002-9257-1817

Afsar Shaikh

Ayyaj A. Badgire

Mohd Salman

Noosrat Jahan Khan

Yayımlanma Tarihi 28 Haziran 2025
Yayımlandığı Sayı Yıl 2023 Cilt: 27 Sayı: 3

Kaynak Göster

APA Khan, N., Qazi, M., Ansari, Y. A., Shaikh, A., vd. (2025). Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination. Journal of Research in Pharmacy, 27(3), 1234-1241.
AMA Khan N, Qazi M, Ansari YA, Shaikh A, Badgire AA, Salman M, Khan NJ. Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination. J. Res. Pharm. Haziran 2025;27(3):1234-1241.
Chicago Khan, Nayeem, Majaz Qazi, Yaasir Ahmed Ansari, Afsar Shaikh, Ayyaj A. Badgire, Mohd Salman, ve Noosrat Jahan Khan. “Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination”. Journal of Research in Pharmacy 27, sy. 3 (Haziran 2025): 1234-41.
EndNote Khan N, Qazi M, Ansari YA, Shaikh A, Badgire AA, Salman M, Khan NJ (01 Haziran 2025) Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination. Journal of Research in Pharmacy 27 3 1234–1241.
IEEE N. Khan, M. Qazi, Y. A. Ansari, A. Shaikh, A. A. Badgire, M. Salman, ve N. J. Khan, “Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination”, J. Res. Pharm., c. 27, sy. 3, ss. 1234–1241, 2025.
ISNAD Khan, Nayeem vd. “Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination”. Journal of Research in Pharmacy 27/3 (Haziran 2025), 1234-1241.
JAMA Khan N, Qazi M, Ansari YA, Shaikh A, Badgire AA, Salman M, Khan NJ. Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination. J. Res. Pharm. 2025;27:1234–1241.
MLA Khan, Nayeem vd. “Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination”. Journal of Research in Pharmacy, c. 27, sy. 3, 2025, ss. 1234-41.
Vancouver Khan N, Qazi M, Ansari YA, Shaikh A, Badgire AA, Salman M, Khan NJ. Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination. J. Res. Pharm. 2025;27(3):1234-41.