G. K. Dyade, Pooja Garad, Pallavi Jadhav
G. K. Dyade, Pooja Garad, Pallavi Jadhav
Dept of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy,
Malegaon (BKII) Baramati, Dist Pune, Maharashtra, India.
Volume - 12,
Issue - 3,
Year - 2022
Quality by design is applied for the development of various pharmaceutical processes including analytical methods. By applying QbD approach chemometric based analytical method was developed for the estimation of amlodipine besylate and telmisartan by UV-VIS spectrophotometry. Solvent 0.1 N HCl was utilised and 291.2 nm and 365.2 nm was the wavelength for measurement of absorbance. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of both the drugs was ascertained over the conc range 5-40mcg/ml. The accuracy was found 104.46% for TEL and 96.25% for AMD; and the precision study was shown acceptable data as %RSD 2.5416 for TEL and 5.7364 for AMD. The developed method is rigid, robust and efficient for the estimation of AMD and TEL, which are in 1: 8 proportionate in the composition of dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage.
Cite this article:
G. K. Dyade, Pooja Garad, Pallavi Jadhav. A QBD Approach in Chemometric assisted Method Development of Telmisartan and Amlodipine besylate by UV-VIS Spectrophotometry. Asian Journal of Pharmacy and Technology. 2022; 12(3):218-4. doi: 10.52711/2231-5713.2022.00036
G. K. Dyade, Pooja Garad, Pallavi Jadhav. A QBD Approach in Chemometric assisted Method Development of Telmisartan and Amlodipine besylate by UV-VIS Spectrophotometry. Asian Journal of Pharmacy and Technology. 2022; 12(3):218-4. doi: 10.52711/2231-5713.2022.00036 Available on: https://ajptonline.com/AbstractView.aspx?PID=2022-12-3-5
1. Alison Brayfield. Martindale (The Complete Drug Reference). 39th ed. Pharmaceutical Press London UK. 2017(A). P. A1332, A1414, A1552.
2. John M. Beale, Jr. John H. Block. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical chemistry. 12th ed. Wolters Kluwer (India) Pvt Ltd New Delhi. 2016.p. 614-654.
3. The Merck Index. An Encyclopaedia of chemicals, drugs and Biological. 15th ed. the Royal Society of Chemistry Cambridge UK. 2013. p. 87, 1840, 1540.
4. Thomas L. Lemke, David A. Williams, Victoria F Roche, S William Zito. Foyes principles of medicinal chemistry. 7th ed (4Th Indian Reprint), Wolters Kluwer (India) Pvt Ltd New Delhi.2018. p. 762,771,827.
5. Saurabh K Sinha, Prabhat K Shrivastava, Sushant K Shrivastava. Development and validation of a HPLC method for the simultaneous estimation of amlodipine and telmisartan in pharmaceutical dosage form. Asian Pacific Journal of Tropical Biomedicine. 2012; 2(1): s312-s315.
6. Dyade G K, Sawant R L, Joshi H A, Shinde A D, Bandal R S, Gadhingleskar S V. A Novel approach: Effect of polarity index of mobile phase on retention time of antihyperlipidaemic antihypertensive and angiotensin inhibiting drugs in RP-HPLC method. Research Journal of Pharmacy and Technology. 2020; 13(7): 3065-3071.
7. Shrikant H Patil, Minakshi V Janjale. Novel and validated titrimetric method for determination of selected angiotensin-II-receptor antagonists in pharmaceutical preparations and its comparison with UV spectrophotometric determination. Journal of Pharmaceutical Analysis. 2012; 2(6): 470-77.
8. S. J. Daharwal, Veena D. Singh. Development of chemometric assisted methods for Simultaneous estimation of Ternary mixture of Telmisartan hydrochloride, Amlodipine besylate and Hydrochlorothiazide. Asian Journal of Pharmacy and Technology. 2015; 5(2): 122-26.
9. Fawzia A. Ibrahim, Amina M. El-Brashy, Mohamed I. El-Awady, Nora A. Abdallah. Assessment of the greenness of spectrophotometric and micellar liquid chromatographic methods using two approaches: Application to pharmaceutical analysis of hydrochlorothiazide and telmisartan. Microchemical Journal. 2019; 148:197-205.
10. N. Vanaja, Ch. Preethi, S.Y. Manjunath, Krishanu Pal. Method Development and Validation for Simultaneous Estimation of Telmisartan and Ramipril by UV-Spectrophotometric Method in Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2015; 5(4):187-194.
11. Dyade G K, Sawant R L. Validated RP-HPLC method and unique mobile phase for the simultaneous estimation of amlodipine besylate and valsartan from solid dosage form and rosuvastatin and valsartan from bulk. Asian Journal of Pharmaceutical and Clinical Research. 2019; 12(4): 156-162.
12. Abhi Kavathia, Manju Misra. Development and validation of RP-HPLC and UV spectrophotometric method for rapid simultaneous estimation of amlodipine and benzepril in pure and fixed dose combination. Arabian Journal of Chemistry. 2017; 10(Suppl): 3021-3028.
13. Ghule A S, Thomas T, Joseph M, Navyasree K S, Bhat. Simultaneous estimation of telmisartan, hydrochlorothiazide and amlodipine besylate in tablet preparation by chemo metric assisted spectrophotometric analysis. Indian Drugs. 2018; 55(7): 59-66.
14. Usharani N., Divya K, Ashrtiha VVS. Development and validation of UV derivative spectroscopic method for the determination of amlodipine besylate and valsartan in tablet dosage form and comparison of the developed methods by student’s t test. Indian Journal of Pharmaceutical Education and Research. 2017; 57(45): 776-82.
15. Vandana M. Patel, Hasumati A. Raj, Vineet C. Jain. Absorbance Correction Method for Simultaneous Estimation of Amlodipine Besylate and Simvastatin in Synthetic Mixture. Asian Journal of Pharmaceutical Research. 2015; 5(2):78-82.
16. Ramesh L Sawant, Rahul B Kale, Amol S Ghodechor, Abhijit B Sherkar, Kunal R Sanklecha. Development and Validation of UV Spectrophotometric Methods for Simultaneous Estimation of Amlodipine besylate and Theophylline. Asian Journal of Pharmaceutical Analysis. 2017; 7(3): 159-162.
17. Saminathan J, Vetrichelvan T. UV spectrophotometric correction method for simultaneous estimation olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide in combined tablet dosage form. Indian Drugs. 2017; 54(11): 33-38.
18. Sushil D. Patil, Rohit B. Badhan, Sanjay J. Kshirsagar. Development and Validation of Q-Absorbance UV Spectrophotometric Method for Simultaneous estimation of Amlodipine Besylate and Candesartan Cilexetil In bulk drugs. Asian Journal of Pharmaceutical Analysis. 2018; 8(1): 53-57.
19. Patel M P, Patel M R, Hasumati R, Noolvi M N, Shah N. Simultaneous estimation amlodipine besylate and indapamide by dual wavelength spectrophotometric method for the combined pharmaceutical dosage form. Indian Drugs. 2014; 51(4): 50-54.
20. Varsha R Galande, K G Baheti, S Indraksha, M H Dehghan. Estimation of amlodipine besylate, valsartan and hydrochlorothiazide in bulk mixture and tablet by UV spectrophotometry. Indian Journal of Pharmaceutical Sciences. 2012; 74(1): 18-23.
21. British Pharmacopoeia. Medicines and Healthcare products regulatory agency London; 2019. pp.I-156, II-1048.
22. Indian Pharmacopoeia, Govt. of India, Ministry of Health and Family Welfare, The Indian Pharmacopoeia Commission Ghaziabad. 8th ed (II, III). 2018; pp.1045, 3319.
23. ICH Expert working group. ICH Harmonized Tripartite Guideline-Pharmaceutical Development Q 8 R2. In Current Step 4 Version. 2009; p. 1-28.
24. ICH Expert working group. ICH harmonized Tripartite Guideline-Quality Risk Management Q 9. In Current Step 4 Version. 2005; p. 1-23.
25. ICH Expert working group. ICH Harmonized tripartite Guideline-Pharmaceutical Quality system Q 10. In Current Step 4 Version. 2008; p. 1-21.
26. 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.
27. Vedantika Das, Bhushan Bhairav, R. B. Saudagar. Quality by Design approaches to Analytical Method Development. Research Journal of Pharmacy and Technology. 2017; 10(9): 3188-94.
28. Yogita M. Kolekar. Understanding of DoE and its advantages in Pharmaceutical development as per QbD Approach. Asian Journal of Pharmacy and Technology. 2019; 9 (4):271-75.
29. Vrushali R. Kadam, M. P. Patil, Vrushali V. Pawar, Sanjay Kshirsagar. A Review on: Quality by Design (QbD). Asian Journal of Research in Pharmaceutical Sciences. 2017; 7(4):197-204.
30. Aditee Mishal, Sudha Rathod. Quality by Design: A New Era of Development of Quality in Pharmaceuticals. Research Journal of Pharmacy and Technology. 2014; 7(5): 581-91.
31. Schweitzer M, Pohl M, Hanna-Brown M, Nethercote P, Bormanare P, Hansen G, et al. Implications and opportunities of applying QbD principles to analytical measurements. Pharm Technology. 2010; 34: 12-29.
32. Vogt F G, Kord A S. Development of quality-by-design analytical methods. Journal of Pharmaceutical science. 2011; 100:797-812.
33. Bhatt D A, Rane S I. QbD approach to analytical RP-HPLC method development and its validation, International Journal of Pharmaceutical Science. 2011; 3:179-187.