Sustainable Green Analytical Chemistry: Spectrophotometric Method Development of Dapagliflozin and Omeprazole by Using Eco-friendly Solvent

  • Sakshi A. Jadhav Department of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati, Pune, Maharashtra, India 413115
  • Nikita A. Bhilare Department of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati, Pune, Maharashtra, India 413115
  • B. Chandanshive Department of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati, Pune, Maharashtra, India 413115
  • Gurappa K. Dyade Department of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati, Pune, Maharashtra, India 413115
  • Amit S. Lunkad Department of Pharmaceutical Chemistry, SitabaiThite College of Pharmacy, Shirur, Pune, Maharashtra, India 412210

Abstract

The present research’s aim was to develop analytical method utilizing ecologically suitable solvent which enhances solubility of analyte, sensitivity of the method etc. An analytical method was developed for the estimation of dapagliflozin (DGZ) and omeprazole (OPZ) by using aqueous 0.1 N HCl on the UV-VIS spectrophotometer. Wavelengths 223 nm and 282.5 nm were set to measure absorbance of DGZ and OPZ respectively. The results of different spectral characteristic techniques were examined to select the parameters and the design was validated against the ICH Q 2 R1 regulatory guidelines. The linearity of the drug was determined at a concentration of 1 to 50μg/ml and 1 to 32μg/ml for DGZ and OPZ respectively.  The accuracy was found within acceptable limit with standard deviation 1.1874 to 6.4984 for DGZ and 0.1401 to 0.9843 for OPZ; and the assay study data was found 99.77 % for DGZ and 97.92 % for OPZ. The stability study of the method was performed out by minute variation in the wavelength, scan speed. The developed method is rigid, robust and efficient for the estimation of DGZ and OPZ from their respective dosage form. The effort was made to develop green or eco-friendly analytical method utilizing hydrotropic solvent for water insoluble drug dapagliflozin and omeprazole.

Keywords: Green method, Dapagliflozin, Omeprazole, analytical method, eco-friendly solvent, UV spectroscopy

References

1. Sabitha Reddy P, Swetha C, Ravindra Reddy K. Effect of Hydrotropes and Physical Properties on Solubility of Glibenclamide. Research J. Pharma. Dosage Forms and Tech. 2011; 3(6): 294-297.
2. Nilesh S. Kulkarni, Sanghamitra B. Ghule, Shashikant N. Dhole. A Review on Hydrotropic Solubilization forPoorly Water Soluble Drugs: Analytical Application and Formulation Development. Research J. Pharm. and Tech. 2019; 12(7):3157-3162.
3. Gurumurthy V., Deveswaran R., Bharath S., Basavaraj B.V., Madhavan V. Application of Hydrotropic Solubilisation in Simultaneous Estimation of Atenolol and Amlodipine Besylate. Asian J. Research Chem. 5(1): January 2012; Page 57-60.
4. Ceema Mathew, Sunayana Varma. Green Analytical Methods based on Chemometrics and UV spectroscopy for the simultaneous estimation of Empagliflozin and Linagliptin. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):43-8.
5. Reem H. Obaydo, Amir Alhaj Sakur. A Green Analytical Method using Algorithm (PCCA) for Extracting Components’ Contribution from Severely Overlapped Spectral Signals in Pharmaceutical Mixtures. Research J. Pharm. and Tech 2019; 12(9):4332-4338.
6. Parixit Prajapati, Chandni Chandarana. Fourier Transform Infrared Spectrophotometry: An Eco-friendly green tool for quantification of Omeprazole in Pharmaceutical formulation. Research Journal of Pharmacy and Technology. 2022; 15(8):3531-4.
7. Haripriya A., Sirisha N., Vishali S., Ramakrishna K., PanikumarA.D.. Validated Eco - Friendly Derivative Spectrophotometric Method for Valsartan and Hydrochlorothiazide Combined Tablet Dosage Form. Asian J. Research Chem. 5(8): August, 2012; Page 1074-1077.
8. Remi. S. L, Joyamma Varkey, R. K. Maheshwari, A. Jayakumaran Nair. A Novel Ecofriendly, cost effective mobile phase for HPLC- Simultaneous estimation and Validation of Paracetamol and Diclofenac sodium in Bulk and Pharmaceutical Formulation by RP-HPLC using Hydrotropic Solution as Mobile phase. Asian J. Pharm. Res. 2020; 10(3):163-170.
9. Yashwant S. Surve, Dharmesh G. Panchal, R.S. Lokhande. A novel methodology for the synthesis of teriflunomide using hydrotropes as a reaction media. Research J. Pharm. and Tech. 2015; 8(9): 1247-1249.
10. The Merck Index, An Encyclopaedia of chemicals, drugs and Biological, 15th edition, the royal society of chemistry Cambridge UK, 2013, pp. 506, 1269.
11. Alison Brayfield, Martindale (The complete drug reference), 39th edition, Pharmaceutical press London, 2017, A: pp. 476, 1902.
12. Mante G V, Gupta K R, Hemke A T. Estimation of Dapagliflozin from Its Tablet Formulation by UV-Spectrophotometry. Pharm Methods. 2017; 8(2):102-7.
13. Jani B R, Shah K V, Kapupara P P. Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Dapagliflozin and Metformin Hydrochloride a Synthetic Mixture. International Journal of Research and Development in Pharmacy & Life Sciences. 2015; 4(3):1569-76.
14. Sen AK, Khatariya SB, Sen DB, Maheshwari RA, Zanwar AS, Velmurugan R. Various Innovative UV Spectroscopic Methodologies for Concurrent Estimation of Dapagliflozin And Vildagliptin In Combined Tablet. Journal of Applied Pharmaceutical Science. 2023; 13(9):213-23.
15. Bhavyasri K, Surekha T, Sumakanth M. A Novel Method Development and Validation of Dapagliflozin And Metormin Hydrochloride Using Simultaneous Equation Method By UV–Visible Spectroscopy in Bulk and Combined Pharmaceutical Formulation Including Forced Degradation Studies. Journal of Pharmaceutical Sciences and Research. 2020; 12(8):1100-5.
16. Barbude P, Tawar M, Burange P. Method Development Using A UV Visible Spectrophotometer for The Simultaneous Estimation of Metformin (Met), Saxagliptin (Sxg), And Dapagliflozin (Dgf) In Marketed Formulation. Asian Journal of Pharmaceutical Analysis. 2022; 12(4): 243-7.
17. Rao B R, Rao V V, Venkateswarlu B S. Rp-Hplc Method for Simultaneous Estimation of Dapagliflozin And Saxagliptin In Bulk Samples. Journal of Pharmaceutical Sciences and Research. 2019; 11(1):254-7.
18. Debata J, Kumar S, Jha SK, Khan A. A New RP-HPLC Method Development and Validation of Dapagliflozin in Bulk and Tablet Dosage Form. Int J Drug Dev Res. 2017; 9(2):48-51
19. Deepan T, Dhanaraju MD. Stability Indicating Hplc Method for The Simultaneous Determination of Dapagliflozin And Saxagliptin In Bulk and Tablet Dosage Form. Current Issues in Pharmacy and Medical Sciences. 2018; 31(1):39-43.
20. Kommineni V, Chowdary K P, Prasad S V. Development of A New Stability Indicating Rp-Hplc Method for Simultaneous Estimation ofSaxagliptine and Dapagliflozin and its Validation as Per ICH Guidelines. Indo American journal of pharmaceutical sciences. 2017; 4(09):2920-32.
21. Singh N, Bansal P, Maithani M, Chauhan Y. Development and Validation of a Stability-Indicating RP-HPLC Method for Simultaneous Determination of Dapagliflozin and Saxagliptin in Fixed-Dose Combination. New Journal of chemistry. 2018; 42(4):2459-66.
22. Manoharan G, Ismaiel A M, Ahmed Z M. Stability-Indicating Rp-Hplc Method Development for Simultaneous Determination and Estimation of Dapagliflozin In Raw and Tablet Formulation. Chem Res J. 2018; 3(2):159-64.
23. Ameeduzzafar, et al. Quality by Design (Qbd) Based Development and Validation Of Bioanalytical Rp-Hplc Method For Dapagliflozin: Forced Degradation And Preclinical Pharmacokinetic Study. Journal of Liquid Chromatography & Related Technologies. 2020; 43(1-2):53-65.
24. Kazi M, Alqahtani A A, Alsaadi B S, Alkholief M, Alanazi F K. UHPLC Method Development for Determining Sitagliptin and Dapagliflozin in Lipid-Based Self-Nanoemulsifying Systems as Combined Dose in Commercial Products and its Application to Pharmacokinetic Study of Dapagliflozin in Rats. Pharmaceutical Chemistry Journal. 2019; 53:79-87.
25. Zaghary WA, Mowaka S, Hendy M S. Kinetic Degradation Study of Dapagliflozin Coupled with UHPLC Separation in the Presence of Major Degradation Product and Metformin. Chromatographia. 2019; 82:777-89.
26. Bueno L, Manoel J W, Koetz M, Henriques A T, Steppe M, Schapoval E E. Simultaneous Analysis of Dapagliflozin and its Three Related Impurities by Stability-Indicating UPLC Method and in Vitro Toxicity Evaluation. Drug Analytical Research. 2022; 6(2):27-37.
27. Mabrouk MM, Soliman SM, El-Agizy HM, Mansour FR. A UPLC/DAD Method for Simultaneous Determination of Empagliflozin and Three Related Substances in Spiked human Plasma. BMC Chemistry. 2019; 13:1-9.
28. Chan-Jiang E, Godoy R, Mennickent S, Vergara C, De Diego M. Determination of the Chemical Stability of Dapagliflozin by LC/DAD and MS/MS Methods. Journal of Chromatographic Science. 2022; 60(8):741-9.
29. Aubry AF, et al. Validated LC–MS/MS Methods for the Determination of Dapagliflozin, a Sodium-Glucose Co-Transporter 2 Inhibitor in Normal and ZDF Rat Plasma. Bioanalysis. 2010; 2(12):2001-2009.
30. Goday S, Shaik AR, Avula P. Development and Validation of a LC-ESI-MS/MS Based Bioanalytical Method for Dapagliflozin and Saxagliptin in Human Plasma. Indian Journal of Pharmaceutical Education and Research. 2018 Oct 1; 52(4): S277-86.
31. Desai S, Maradia RB, Suhagia BN. A Comprehensive and Critical Review on Analytical and Bioanalytical Methods for Metformin Hydrochloride, Dapagliflozin, and Saxagliptin. Current Pharmaceutical Analysis. 2023; 19(1):20-50.
32. British Pharmacopoeia, Medicines and Healthcare products regulatory agency London, 2019, II: 1231.
33. Indian Pharmacopoeia, Govt of India, ministry of Health and family welfare, 8th edition, The Indian pharmacopoeia commission Ghaziabad, 2018, III: pp. 2783.
34. Rivai H, Hasanah R, Azizah Z. Development and validation of omeprazole analysis methods in capsules with absorbance methods and areas under curves methods with UV-Vis spectrophotometry. International Journal of Pharmaceutical Sciences and Medicine. 2018; 3(3): 21-32.
35. Patel R K, Patel H R, Patel V A, Ganure A L, Patel L J. Development and validation of RP-HPLC method for simultaneous determination of omeprazole and diclofenac sodium in capsule dosage form. J. Pharm. Res. 2012; 5:1640-1642.
36. Trivedi HK, Patel MC. Development and Validation of a Precise single HPLC Method for Determination of Omeprazole and its related compound in pharmaceutical formulation. Int J Chem Tech Research. 2010; 2:1355-67.
37. Kayesh R, Sultan MZ, Rahman A, Uddin MG, Aktar F, Rashid MA. Development and validation of a RP-HPLC method for the quantification of omeprazole in pharmaceutical dosage form. Journal of Scientific Research. 2013; 5(2):335-42.
38. Iuga C, Bojita M, Leucuta S E. Development of a validated RP-HPLC method for separation and determination of process-related impurities of omeprazole in bulk drugs. Farmacia. 2009; 57(5):534-41.
39. Nataraj KS, Duza MB, Pragallapati K, Kumar DK. Development and validation of RP-HPLC method for the estimation of omeprazole in bulk and capsule dosage forms. International current pharmaceutical Journal. 2012; 1(11):366-9.
40. Gopalakrishnan S, Jothy K, Dhanalakshmi K. Analytical method development and validation of HPLC method for the determination of omeprazole in capsule dosage form. Elixir Appl. Chem. 2012; 52:11283-11286.
41. Schubert A, Werle AL, Schmidt CA, Codevilla C, Bajerski L, Chiappa R, Cardoso S G. Determination of omeprazole in bulk and injectable preparations by liquid chromatography. Journal of AOAC International. 2003; 86(3):501-504.
42. Koppala S, Ranga Reddy V, Anireddy JS. Development and validation of a novel stability-indicating RP-HPLC method for the simultaneous determination of related substances of ketoprofen and omeprazole in combined capsule dosage form. Journal of chromatographic science. 2016; 54(5):765-75.
43. Jha P, Parveen R, Khan SA, Alam O, Ahmad S. Stability-indicating high-performance thin-layer chromatographic method for quantitative determination of omeprazole in capsule dosage form. Journal of AOAC International. 2010; 93(3):787-791.
44. Manranjan VC, Yadav DS, Jogia HA, Chauhan PL. Design of experiment (DOE) utilization to develop a simple and robust reversed-phase HPLC technique for related substances’ estimation of omeprazole formulations. Scientia Pharmaceutica. 2013; 81(4):1043-1056.
45. Lou J, Yu L, Li J, Liu J, Ding Q, Chen W, Sun L, Zhang Y. Development and validation of a HPLC method for the estimation of omeprazole in human plasma. Lat. Am. J. Pharm. 2016; 35(2):239-243.
46. Garcıa-Encina G, Farranlo R, Puig S, Martı́nez L. Validation of an automated liquid chromatographic method for omeprazole in human plasma using on-line solid-phase extraction. Journal of pharmaceutical and biomedical analysis. 1999; 21(2):371-82.
47. Ahmad L, Iqbal Z, Nazir S, Shah Y, Khan A, Khan MI, Nasir F, Khan A. Optimization and validation of HPLC-UV method for simultaneous determination of omeprazole and its metabolites in human plasma: effects of various experimental conditions and parameters. Journal of liquid chromatography & related technologies. 2011; 34(15):1488-501.
48. Jadhav SB, Kumar CK, Bandichhor R, Bhosale PN. Development of RP UPLC-TOF/MS, stability indicating method for omeprazole and its related substances by applying two level factorial design; and identification and synthesis of non-pharmacopoeial impurities. Journal of Pharmaceutical and Biomedical Analysis. 2016; 118:370-379.
49. El-Kimary EI, Ragab M A. A validated high-performance thin-layer chromatographic method for the assay of two binary mixtures containing omeprazole or its isomer esomeprazole in pharmaceutical dosage forms. JPC–Journal of Planar Chromatography–Modern TLC. 2015; 28:74-82.
50. Patel B, Patel M, Patel J, Suhagia B. Simultaneous determination of omeprazole and domperidone in capsules by RP‐HPLC and densitometric HPTLC. Journal of liquid chromatography & related technologies. 2007; 30(12):1749-1762.
51. Agbaba D, Novovic D, Karljiković-Rajić K, Marinković V. Densitometric determination of omeprazole, pantoprazole, and their impurities in pharmaceuticals. JPC-Journal of Planar Chromatography-Modern TLC. 2004; 17(3):169-172.
52. ICH Expert working group. ICH Harmonized tripartite Guideline-Pharmaceutical Quality system Q 10. In current step 4Thversion. 2008; p. 1-21.
53. ICH Expert working group. ICH Harmonized tripartite Guideline-Validation of analytical procedures: Text and methodology Q 2 R1. In current step 4 version. 2005; p. 1-17.
54. Byrne, F.P., Jin, S., Paggiola, G. et al. Tools and techniques for solvent selection: green solvent selection guides. Sustain Chem Process. 2016; 4(7): 1-24. Doi.org/10.1186/s40508-016-0051-z
Statistics
265 Views | 235 Downloads
How to Cite
Sakshi A. Jadhav, Nikita A. Bhilare, B. Chandanshive, Gurappa K. Dyade, and Amit S. Lunkad. “Sustainable Green Analytical Chemistry: Spectrophotometric Method Development of Dapagliflozin and Omeprazole by Using Eco-Friendly Solvent”. Current Research in Pharmaceutical Sciences, Vol. 13, no. 4, Mar. 2024, pp. 179-87, doi:10.24092/CRPS.2023.130404.
Section
Research Articles