SIMULTANEOUS ESTIMATION OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY HPTLC
Keywords:Valsartan, Hydrochlorothiazide, HPTLC, Tablet dosage Form, ICH guidelines
Objective: The prevalence of Hypertension in India is estimated to be greater than 45% in middle age population, Elevated hypertension is one of the known causes of CHD, strokes and death. The objective of this work was to develop a simple, accurate and robust HPTLC method was developed for simultaneous estimation of Valsartan and Hydrochlorothiazide in bulk and tablets.
Methods: The mobile phase optimized by HPTLC method consists of Toluene: Ethyl acetate: formic acid in the ratio of (3:7:0.3, v/v/v). The solvent front was run up to distance of 80 cm; which took 15 mins for development of TLC plate. Analytical Wavelength for UV detection selected was at 225 nm.
Results: Retention factor was found to be 0.74 ± 0.02 and 0.45 ± 0.02 for VAL and HTZ respectively. Developed chromatographic method was validated as per ICH, Q2(R1) guidelines. Linearity was found at concentration range 300-1800 ng/spot (r2 = 0.999), 50-300ng/spot (r2 = 0.9991) for VAL and HTZ respectively. LOD were found to be 23.02 ng/spot and 4.12ng/spot respectively for Valsartan and Hydrochlorothiazide. LOQ was found to be 69.76ng/spot and 12.5ng/spot for, Valsartan and Hydrochlorothiazide respectively.
Conclusion: Percentage RSD was found out to less than 2 indicating the developed method was precise and can be successively applied to pharmaceutical formulation. No interferences with the excipients were reported.
PubChem [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biotechnology Information; 2004-. PubChem Compound Summary for CID 60846, Valsartan; [cited 2022 Mar. 14]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Valsartan
United State Pharmacopoeia, The U.S. Pharmacopeia Convention, United State Pharmacopoeia, Rockville, Md, USA, 30th edition, 2007.
Shah NJ, Suhagia BN, Shah RR, Patel NM. HPTLC Method for the Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form. Indian J Pharm Sci. 2009 Jan;71(1):72-4. doi: 10.4103/0250-474X.51967. PMID: 20177464; PMCID: PMC2810056.
Shaalan RA, Belal TS, Fawzy A.El Yazbi, Elonsy SM. Validated HPTLC methods for determination of some selected antihypertensive mixtures in their combined dosage forms. Bulletin of Faculty of Pharmacy, Cairo University. 2014 December; 52(2):225-237. https://doi.org/10.1016/j.bfopcu.2014.07.001
Pandya JJ, Sanyal M, Shrivastav PS. Simultaneous densitometric analysis of amlodipine, hydrochlorothiazide, lisinopril and valsartan by HPTLC in pharmaceutical formulations and human plasma. Journal of Liquid Chromatography. 2017;9:467-478. https://doi.org/10.1080/10826076.2017.1324482
Jadhav M L, Girase M V, Tidme SK, Junagade MS, Development and Validation of Spectrophotometric Methods for Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form, Int J of Spectroscopy,2014, Article ID 873819, 6 pages, https://doi.org/10.1155/2014/873819.
Sharma M, Kothari C, Sherikar O, Mehta P. Concurrent Estimation of Amlodipine Besylate, Hydrochlorothiazide and Valsartan by RP-HPLC, HPTLC and UV–Spectrophotometry. Journal of Chromatographic Science. 2014 Jan;52(1):27–35, https://doi.org/10.1093/chromsci/bms200.
Kadam BR, Bari SB. Quantitative analysis of valsartan and hydrochlorothiazide in tablets by high performance thin-layer chromatography with ultraviolet absorption densitometry. Acta Chromatogrphica. 2007;18:260-269.
Deshpande MM, Mahajan MP, Sawant SD. Simultaneous estimation of valsartan and hydrochlorothiazide in fixed dose combination in UV spectrophotometry. Int J of Pharm sci and Research. 2012; 3(1):236-240.
Tian DF, Tian XL, Tian T, Wang ZY, Mo FK. Simultaneous Determination of Valsartan and Hydrochlorothiazide in Tablets by RP-HPLC, Indian J Pharm Sci. 2008 May-Jun;70(3):372–374.
Singh S, Yadav AK, Gautam H. Simultaneous estimation of valsartan and hydrochlorothiazide in solid dosage form using UV spectroscopy. Bulletin of Pharm Research. 2011;1(3):10-12.
Sethi. PD. HPTLC: Quantitative Analysis of Pharmaceutical Formulations. CBS Publications, New Delhi. 1996;76-80.
ICH, Q2(R1), Harmonized Tripartite Guideline, Validation of analytical Procedure Methodology, IFPMA, Proceedings of the International Conference on Harmonization, Geneva, November 2005.
ICH Guidance on Analytical Method Validation, in: Proceeding of The International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September,2002.
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Copyright (c) 2022 MRUNALINI H. KULKARNI, POONAM R. INAMDAR, PALLAVI DHEKALE, AMRITA THAKUR, SWATI MUTHA, NEETA RAI, VISHAL GALAVE
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