Author(s):
R. Anantha Kumar, G. Raveendra Babu, M. Sowjanya, M. Ramayyappa
Email(s):
ananth2.pharma@gmail.com
DOI:
10.52711/2231-5675.2021.00037
Address:
R. Anantha Kumar1*, G. Raveendra Babu2, M. Sowjanya3, M. Ramayyappa2
1Nova College of Pharmacy, Jangareddy Gudem, Andhra Pradesh, India.
2A.K.R.G. College of Pharmacy, Nallajerla, Andhra Pradesh, India.
3Vijaya Teja Degree College, Addanki, Andhra Pradesh, India.
*Corresponding Author
Published In:
Volume - 11,
Issue - 3,
Year - 2021
ABSTRACT:
The aim of this work is to build up a fast, exact, precise and touchy reverse phase liquid chromatographic method for the synchronous assessment of amiloride and hydrochlorothiazide in tablet dose structure. The chromatographic strategy was normalized utilizing Hypersil ODS segment (250×4.6mm, 5µm molecule size) with UV discovery at 210nm and stream pace of 1ml/min. The portable stage includes phosphate buffer (pH acclimated to 2.5 with dilute Ortho Phosphoric acid) and acetonitrile in the proportion of 60:40 v/v. The linearity of proposed technique was examined in the scope of 5-30µg/ml (R²=0.999) for amiloride and 50-300µg/ml (R²=0.999) for Hydrochlorothiazide appropriately. The limit of detection (LOD) was discovered to be 0.10µg/ml and 0.40µg/ml for Amiloride and Hydrochlorothiazide appropriately. The limit of quantitation (LOQ) was discovered to be 0.30µg/ml and 1.20µg/ml for Amiloride and Hydrochlorothiazide separately. The retention times of Amiloride and Hydrochlorothiazide were found to be 3.258min and 2.383min separately. The technique was truly recommended and %RSD was found to be under 2 demonstrating serious level of exactness and accuracy. Subsequently proposed strategy can be effectively evaluated for the synchronous assessment of Amiloride and Hydrochlorothiazide in promoted formulations.
Cite this article:
R. Anantha Kumar, G. Raveendra Babu, M. Sowjanya, M. Ramayyappa. Validated RP-HPLC method for the estimation of Amiloride and hydrochlorothiazide in combined tablet dosage form. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):207-1. doi: 10.52711/2231-5675.2021.00037
Cite(Electronic):
R. Anantha Kumar, G. Raveendra Babu, M. Sowjanya, M. Ramayyappa. Validated RP-HPLC method for the estimation of Amiloride and hydrochlorothiazide in combined tablet dosage form. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):207-1. doi: 10.52711/2231-5675.2021.00037 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-3-7
REFERENCES:
1. The Merck Index, 23rd ed. Whitehouse Station, New Jersey; 2008. p. 516, 6235.
2. Martindale, Sweetman SC. The Complete Drug Reference. 32nd ed. Pharmaceutical Press; 1999. p. 822, 907.
3. Oneil MJ, Smith A, Heckelman PE, Budawari S. The Merck Index, an Encyclopedia of Chemicals, Drugs and Biologicals, 13rd ed., Merck and Co Inc., White House Station, New Jersey; 2001. p. 488, 865.
4. British Pharmacopoeia, Vol. 1, The Stationery Office, London, UK, 2007.
5. P. Pickkers, R. S. Garcha, M. Schachter, P. Smits, and A. D. Hughes, “Inhibition of carbonic anhydrase accounts for the direct vascular effects of hydrochlorothiazide. Hypertension. Vol. 33, no. 4, pp. 1043–1048, 1999.
6. Chandan Kumar Giri, Kondawar MS, Chougule DD. Simultaneous estimation of Nebivolol hydrochloride and Amlodipine besylate in combined tablet dosage form by Q-analysis method. IJPRD/PUB/ARTI/VOV-2/ISSUE-5/JULY/013.
7. Bhatia NM, Mohite AS, Bhatia MS. Simultaneous spectrophotometric estimation of atenolol and amlodipine besylate by multiwavelength method. The Indian Pharmacist. 2007; 6: 59-62.
8. Chandrashekhar TG, Rao PSN, Smrita K. Analysis of amlodipine besylate by HPTLC with fluorimetric detection: a sensitive method for assay of tablets. J. Planar. Chromatogr. Mod. TLC 1994; 7: 458.
9. Pandya KK, Satia M, Gandhi TP. Detection and determination of total amlodipine by high performance thin layer chromatography: A useful technique for pharmacokinetic studies. J Chromatogr B Biomed Appl. 1995; 667(2): 315-20.
10. Alaa El Gindy, Ahmed Ashour, Laila Abdel Fattah. Application of LC and HPTLC Densitometry for the Simultaneous determination of Benazepril Hydrochloride and Hydrochlorothiazide. J Pharm Biomed Anal. 2001; 25(2): 171-9.
11. Ilango K, Kumar PB, Prasad VRV. Simple and rapid high performance thin layer chromatographic determination of amlodipine in pharmaceutical dosage forms. Indian J. Pharm. Sci 1997; 59: 336.
12. Shah NJ, Suhagia BN, Shah RR, Shah PB. Development and validation of HPTLC method for Simultaneous estimation of Telmisartan and Hydrochlorothiazide in tablet dosage form. Indian J of Pharm Sci. 2007; 69: 202-5.
13. Carlucci G, Palumbo G, Mazzeo P, Quaglia MG. Simultaneous determination of losartan and hydrochlorothiazide in tablets by high performance liquid chromatography. J Pharm Biomed Anal 2000; 23(1): 185-9.
14. Patel Gaurav, Patel Sanjay et al. RP-HPLC Method for Simultaneous Estimation of Amlodipine Besylate and Hydrochlorothiazide in Combined Dosage Forms. S. J. Pharm. Sci 2010; 3(1): 49-53.
15. Kartal M, Erk N. Simultaneous determination of Hydrochlorothiazide and Amiloride Hydrochloride by Ratio Spectra Derivative Spectrophotometry and High-Performance Liquid Chromatography. J Pharm Biomed Anal. 1999; 19(3-4): 477-85.
16. Safeer K, Anbarasi B, Senthil Kumar N. Analytical Method Development and Validation of Amlodipine and Hydrochlorothiazide in combined dosage form by RP-HPLC. Int. J. Chem Tech Res. 2010; 2(1): 21-25.
17. M. A. Gotardo, L. Pezza, and H. R. Pezza. Determination of hydrochlorothiazide in pharmaceutical formulations by diffuse reflectance spectroscopy. Ecletica Quımica. Vol. 30, no. 2, pp. 17–24, 2005.
18. S. A. Hapse, V. S. Wagh, P. T. Kadaskar, M. D. Dokhe, and A. S. Shirsath. Spectrophotometric estimation and validation of hydrochlorothiazide in tablet dosage forms by using different solvents. Der Pharma Chemica. Vol. 4, no. 1, pp. 10–14, 2012.
19. A. M. Idris and R. E. E. Elgorashe. Sequential injection chromatography with a miniaturized multi-channel fiber optic detector for separation and quantification of propranolol and hydrochlorothiazide. Chemistry Central Journal. Vol. 5, article 28, pp. 1–8, 2011.
20. P. N. Bhoya, E. M. Patelia, and Gautambhai. Development and validation of TLC-densitometry method for simultaneous estimation of Bisoprolol fumarate and hydrochlorothiazide in bulk and tablets. Journal of Chromatography and Separation Techniques. Vol. 4, no. 1, article 163, 4 pages, 2013.
21. S. Gayathri, D. Sireesha, M. A. Haque, S. Harshini, V. Bhakshi, and S. K. Reddy. Method development and validation of RP-HPLC method for simultaneous estimation of Olmesartan medoxomil and Hydrochlorothiazide in bulk and pharmaceutical dosage form. International Journal of Pharma Research and Health Sciences. Vol. 2, no. 6, pp. 457–462, 2014.
22. M. Mahesh, R. Kumanan, and K. N. Jayaveera, “Isocratic RPHPLC UV Method development and validation for the simultaneous estimation of hydrochlorothiazide and Ramipril in tablet dosage form and bulk durg. International Journal of Current Pharmaceutical Research. Vol. 3, no. 2, pp. 119–123, 2011.
23. Z. Vujic, N. Mulavdi, M. Smaji, J. Brbori, and P. Stankovic. Simultaneous analysis of irbesartan and hydrochlorothiazide: an improved HPLC method with the aid of a chemometric protocol. Molecules. vol. 17, no. 3, pp. 3461–3474, 2012.
24. B. V. Savaj, H. A. Raj, S. Rajanit, and S. Harshita, “Analytical techniques for determination of hydrochlorothiazide and its combinations: a review,” International Journal of Advances in Scientific Research, vol. 1, no. 3, pp. 114–128, 2015.
25. Analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2(3): July-Sept. 2012; Page 85-89.
26. K. Vijaya Sri, M. Anusha, S. Ravinder Reddy. A Rapid RP-HPLC Method development and Validation for the Analysis of Linagliptinin Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 5(1): Jan.- March 2015; Page 16-20.
27. B. Mohan Gandhi, A. Lakshmana Rao, J. Venkateswara Rao. A New Stability-Indicating and Validated RP-HPLC Method for the Estimation of Tolvaptan in Bulk and Pharmaceutical Dosage Forms. Asian J. Research Chem. 7(7): July 2014; Page 628-633.
28. Vatchavai Bhaskara Raju, Bonthu Mohan Gandhi, Kamatham Srinivas Sumanth, Kolli Srinivas, Tupakula N Venkata Lakshmi Neeraja. RP-HPLC Method Development and Validation for Simultaneous Estimation of Telmisartan and Ramipril in pure and Pharmaceutical Dosage forms. Asian J. Research Chem. 2017; 10(2): 179-185.
29. Ashwini Parmar, Sandeep Sonawane, Santosh Chhajed, Sanjay Kshirsagar. Development and Validation of RP-HPLC Method for simultaneous estimation of Telmisartan, Amlodipine Besylate and Hydrochlorthiazide in their tablet dosage form. Asian J. Pharm. Ana. 2017; 7(3): 189-195.
30. S. J. Daharwal, Veena D. Singh. Development of classical least square method for the determination of Candesartan and Hydrochlorthiazide in tablet dosage form. Asian J. Pharm. Res. 5(2): April-June 2015; Page 90-95.
31. S. J. Daharwal, Veena D. Singh. Estimation of Binary Mixtures of Captopril and Hydrochlorthiazide by using Chemometric Assisted Method. Asian J. Pharm. Tech. 2015; Vol. 5: Issue 2, Pg 79-82.
32. T Venkatachalam, V Kishor Kumar, P Kalai Selvi, R Srinivasan, R Mariammal, KG Lalitha. New Spectrophotometric Method Applied to the Simultaneous Determination of Metoprolol Succinate and Hydrochlorthiazide. Asian J. Research Chem. 3(2): April- June 2010; Page 464-467.
33. G. Saravanan, SK. Bajidbhee, I. Sri Krishnanjaneyulu. Development and validation of RP-HPLC method for simultaneous estimation of Hydrochlorthiazide and Olmesartan medoxomil in bulk and pharmaceutical dosage form. Asian J. Research Chem 8(2): February 2015; Page 147-152.
34. Devika G.S., M. Sudhakar, J. Venkateshwara Rao. Isocratic RP-HPLC Method for Simultaneous Estimation of Spirinolactone and Hydrochlorthiazide in Oral Solid Dosage Form. Research J. Pharm. and Tech. 5(8): August 2012; Page 1050-1053.
35. ICH, Q2A, Text on validation of analytical Procedures International Conference on Harmonization, Geneva 1994: 1-5.
36. ICH, Q2B, Validation of analytical Procedure: Methodology, International Conference on Harmonization, Geneva 1996: 1-8.
37. ICH, Q2R1, Text on validation of analytical Procedures International Conference on Harmonization, Geneva 1994: 1-13.