Abstract

For the simultaneous quantification of Azelnidipine and Chlorthalidone in synthetic combination, a high performance thin layer chromatographic method was devised that is quick, accurate, selective, and exact. The mobile phase used in the chromatographic analysis was in the ratio of 5: 4.7: 0.3: 0.1 v/v/v/v, and the stationary phase utilised was silica gel 60 F254 as the precoated stationary phase on aluminium plates. A 10 x 20 cm TLC chamber with a 15-minute saturation period was utilised. Azelnidipine and chlorthalidone were found to have retardation factors (RF) of 0.43 0.03 and 0.30 0.02, respectively. At 242 nm, densitometric analysis was performed. Following the ICH Q2 (R1) standard, a validation study was conducted. The calibration plots' regression data revealed a strong linear association with R2 = 0.999 for the concentration ranges of azelnidipine and chlorthalidone, 400–1200 ng band-1 and 600–1800 ng band-1, respectively. The method's precision, accuracy, and robustness were all validated. For azelnidipine and chlorthalidone, the minimum detectable levels were determined to be 26.71 ng band-1 and 38.39 ng band-1, respectively, and the limits of quantitation were found to be 80.94 ng band-1 and 116.033 ng band-1. Azelnidipine and chlorthalidone can be estimated simultaneously for routine analysis, in drug formulations, and in biological matrices, in short, using the proven analytical approach.

Keywords

Azelnidipine, Chlorthalidone, High-Performance Thin-Layer Chromatographic method, Validation,

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References

  1. Indian Pharmacopoeia, (2018) Government of India, Ministry of Health and Family Welfare, The Indian Pharmacopoeia Commission, Ghaziabad, Ⅱ, 1304-1307.
  2. Japanese Pharmacopoeia, (2016) 17th Edition, Ministry of Health, Labour and Welfare, 463.
  3. Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare, Published by the Indian Pharmacopoeia Commission, Ghaziabad, Ⅱ (2010) 1076-1077.
  4. British Pharmacopoeia, Her Majesty’s Stationery Office, London, Ⅰ(2009) 1306-1307.
  5. I.H. Mukeri, A.K. Kushwaha, N.P. Neupane, A. Kumar, A. Sushant, A. Nag P. Malairajan, Analytical method development and Validation of Azelnidipine by UV-Visible spectroscopy, World Journal of Pharmaceutical Research, 10(10) (2021) 858-872.
  6. S.S. Sonawane, P.C. Bankar, S.J. Kshirsagar, Stability-indicating LC method for Quantification of Azelnidipine: Synthesis and Characterization of Oxidative Degradation Product, Turk. J. Pharm. Sci. 18(5) (2021) 550-556.
  7. M. Kumar, U. Chandra, A. Garg, P. Gupta,A Stability indicating RP-HPLC method validation for Simultaneous estimation of Azelnidipine and Telmisartan in a Fixed-dose combination, International Journal of Pharmaceutical Sciences and Drug Research, 13(3) (2021) 288-294.
  8. M.A. Amin, A.S. Amin, M.Z. Saad, Stability indicating ultra-fast liquid chromatography coupled with photodiode array method for simultaneous estimation of Azelnidipine and Olmesartan medoxomil in pharmaceutical formulations, Journal of Pharmaceutical Science and Technology, 9 (2019) 9-14.
  9. D. Prabhakar, J. Sreekanth, K.N. Jayaveera, Method development and validation of Azelnidipine by RP-HPLC, International journal of Chemtech Research, 10(10), (2017) 418-423.
  10. R. Adepu, B. Neelima, L.M.K. Pallapothu, A. Kumar, A novel method for the simultaneous determination of Azelnidipine and Olmesartan in human plasma by using liquid chromatography-electro spray ionization tandem mass spectrometry and application to a pharmacokinetic study, International Journal of Pharmaceutical Sciences Research, 7(3), (2017) 111-124.
  11. A.S. Rane, S.K. Mahajan, Validation and Forced stability indicating HPTLC method for determination of Azelnidipine, World Journal of Pharmaceutical Research, 5(9), (2016) 1053-1062.
  12. A.A. Amin, M.Z. Saad, M.A.A. Ahmed, simultaneous determination of Azelnidipine and Olmesartan Medoxomil in pharmaceutical dosage forms by UFLC method, Journal of Pharmaceutical Science and Technology, 6(2), (2016) 69-74.
  13. M.G. Gore, P.S. Dabhade, RP-HPLC method development and validation of Azelnidipine, International Journal of Pharmaceutical Sciences Research, 7(12) (2016) 5111-5114.
  14. J. Modi, S.K. Patel, N. Parikh, S.R. Shah, P.K. Pradhan, U.M. Upadhyay, Stability indicating analytical method development and validation for estimation of Azelnidipine, World Journal of Pharmaceutical Research, 5(2), (2015) 831-847.
  15. Y. Gao, B. Li, B. Zhu, D. Liu, H. Zhao, Z. Fang, H. Wang, H. Lou, A liquid chromatography-tandem mass spectrometric assay for the antihypertensive agent azelnidipine in human plasma with application to clinical pharmacokinetics studies, Biomed Chromatogr, 29, (2015) 970-974.
  16. J.K. Patel, N.K. Patel, Validated stability-indicating RP-HPLC method for the simultaneous determination of Azelnidipine and Olmesartan in their combined dosage form, Scientia Pharmaceutica, 82(3) (2014) 541-554.
  17. R.B Ganduri, J.R. Peddapapireddigar, H. Vurimindi, Rampraksah, Stability indicating liquid chromatographic method for the simultaneous determination of Olmesartan Medoxomil and Azelnidipine in combined tablet dosage form, International Journal of Pharma Sciences and Research, 5 (2014) 275-282.
  18. G. Suneetha, P. Venkateswarlu, P.S.S. Prasad, Sensitive analysis of Azelnidipine and related derivative in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry, Asian Journal of Chemistry, 25(18) (2013) 10319-10321.
  19. K.D. Raskapur, M.M. Patel, A.D. Captain, UV-Spectrophotometric method development and validation for determination of Azelnidipine in pharmaceutical dosage form, International journal of pharmaceutical sciences research, 4(1) (2012) 238-240.
  20. K. Kawabata, Y. Urasaki, Simultaneous determination of azelnidipine and two metabolites in human plasma using liquid chromatography-tandem mass spectrometry, Journal of Chromatography B, 844, (2006) 45-52.
  21. S. Tamizhselvi, T. Sudha, Development and validation of first order derivative UV spectrophotometric method for the estimation of Telmisartan, Metoprolol succinate and Chlorthalidone in bulk and tablet dosage form, European journal of biomedical & pharmaceutical sciences, 8(6) (2021) 362-365.
  22. C. Kharat, V.A. Shirsat, Y.M. Kodgule, M. Kodgule, A validated RP-HPLC stability method for the estimation of Chlorthalidone and its process-related impurities in an API and tablet formulation, International Journal of Analytical Chemistry, 2020 (2020) 1-11.
  23. P.G. Nikalje, R. Gadikar, A Simple HPTLC method for simultaneous estimation of Atenolol and Chlorthalidone in pharmaceuticals, Chemistry Journal, 6 (2020) 35-47.
  24. D.A. Gol, A.J. Vyas, R.G. Usdad, A.I. Patel, A.B. Patel, N.K. Patel, A. Chudasama HPTLC-Densitometric method for simultaneous estimation of Olmesartan medoxomil and Chlorthalidone in tablet dosage form. Ana, Chemistry Journal, 2020 10(4) 498-506.
  25. S.V. Gandhi, A.P. Sanklecha, HPLC method development and validation for estimation of Chlorthalidone in tablet dosage form, J. drug Deliv. Ther. 2019; 9(4):53-56.
  26. S.S. Bamgonde, K.C. Dulange, M.S. Kalshetti, Z.M. Gaibu, N.R. Gate, UV-Spectrophotometric method development and validation for determination of Chlorthalidone in bulk and pharmaceutical dosage form, Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry, 7(1) (2019) 8-15.
  27. V.S. Solanki, R.S. Bishnoi, R. Baghel, D. Jain, RP-HPLC method development and validation for simultaneous estimation of Cilnidipine, Atenolol and Chlorthalidone, Journal of Drug Delivery and Therapeutics, 8(6-s) (2018) 78-82.
  28. V. Sawale, D.M. Dhabarde, D.B. Mahapatra, Development and validation of UV Spectrophotometric method for simultaneous estimation of Olmesartan medoxomil and Chlorthalidone in bulk and tablet, Eurasian Journal of Analytical Chemistry, 12(1), (2017) 55-66.
  29. R.K. Dagariya, R.K. Jat, Method development and validation of Irbesartan Chlorthalidone and Cilnidipine in their combined tablet dosage form by high performance liquid chromatography, Journal of Drug Delivery and Therapeutics, 7(4) (2017) 88-96.
  30. J.V. Shah, D.P. Patel, P.A. Shah, M. Sanyal, P.S. Shrivastav, Simultaneous quantification of Atenolol and Chlorthalidone in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry, biomed. Chromatogr, 30 (2016) 208-216.
  31. S.N. Patel, M.A. Hinge, V.M. Bhanushali, Development and validation of an UV spectrophotometric method for simultaneous determination of Clinidipine and Chlorthalidone, Eurasian Journal of Analytical Chemistry, 9(1) (2015) 41-45.
  32. P. Dangre, V. Sawale, S. Meshram, M.Gunde, Development and validation of RP-HPLC method for the simultaneous estimation of Eprosartan mesylate and Chlorthalidone in Tablet, Dosage form, International Journal of PharmTech Research, 8(2) (2015)163-168.
  33. V.M. Bhanushali, M.A. Hinge, SN. Patel, Development and validation of an UV spectrophotometric method for simultaneous determination of Chlorthalidone and Losartan Potassium, Journal of Pharmacy Research, 9(1) (2015) 54-59.
  34. N.S. Abdullah, M.A. Hassan, R.O. Hassan, Spectrophotometric determination of Chlorthalidone in pharmaceutical formulations using different order derivative methods, Arabian Journal of Chemistry, 10(s-2), (2017) S3426-S3433.
  35. W.M. Ebeid, E.F. Elkady, A.A. El-Zaher, R.I. El-Bagary, G. Patonay, Spectrophotometric and spectrofluorimetric studies on Azilsartan medoxomil and chlorthalidone to be utilized in their determination in Pharmaceuticals, Analytical chemistry insights, 9 (2014) 33-40.
  36. S.U. Ingle, P.A. Patil, V.C. Kulkarni, S.V. Patil, P.A. Salunke, R.S. Wagh, Development and Validation of UV spectrophotometric method for Chlorthalidone in bulk and pharmaceutical dosage forms, World Journal of Pharmaceutical Research, 3(9), (2014) 958-963.
  37. H.M. Akiful, G. Nivedita, P.K. Kumar, P.T. Kumar, A.S. Hasan, P.V. Diwan, Simultaneous estimation of Atenolol and Chlorthalidone as bulk and in tablet dosage form using UV-Spectrophotometry, Journal of Pharmacy and Biological Sciences, 1(4), (2012) 20-23.
  38. H.R. Raval, D.M. Patel, C.N. Patel, Estimation of Metoprolol Tartrate and Chlorthalidone in combined dosage form by UV-Spectrophotometric methods, Research Journal of Pharmacy and Technology, 4(8) (2011) 204-1206.
  39. I.H.T. Guideline, (2005). Validation of analytical procedures: text and methodology, Q2 (R1), 1(20) 05.