Stress degradation studies of hydrochlorothiazide and development of validated method by UV spectroscopy

Devi velmurugan


To develop a simple, precise, accurate, and stability indicating a UV-method for estimation of Hydrochlorothiazide(HCT)in bulk and formulated dosage form.The drug was alsosubjected to stress degradation at different conditions recommended by the International Conference on Harmonization (ICH). The samples are generated and used for the degradation studies.The λmax of the HCTwas found to be 273nm.The linearity of calibration curve (Absorbance Vs Concentration) in pure solution was checked over the concentration ranges of about 5-30μg/mLwith the correlation coefficient higher than 0.99. The regression equation of the curve was Y = 0.598x + 0.0042.% RSD was found to be within the limit as per ICH guidelines. The obtained percentage recovery of HCTwas found to be within the limit100% ± SD.  Stress degradation studies revealed thatitwas within the limit(5-20%).


UV Spectroscopy; Hydrochlorothiazide; Stress degradation; validation

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MHPRA. Hydrochlorothiazide In British Pharmacopoeia, Stationary Office: London, UK, 2008; Vol. 1, pp 1080-1082.

IPC. Hydrochlorothiazide. In Indian Pharmacopoeia, Indian Pharmacopoeial Commission (IPC), Ministry of Health and Family Welfare: Ghaziabad, Delhi, 2014; Vol. 1, pp 1900-1902.

Tripathi, K. D., Essentials of Medical Pharmacology. 6th ed.; JP Medical Ltd: 2006, 565-568.

Khan, M. R.; Shaikh, A.; Thaker, A. K. Simultaneous determination and method development for assay of Losartan potassium and Hydrochlorothiazide drugs in solid dosage form by RP-HPLC. Indian J Pharm Sci Res 2012, 2 (1), 42-45.

Deshpande, M. M.; Mahajan, M. P.; Sawant, S. D. Simultaneous estimation of Valsartan and Hydrochlorothiazide in fixed dose combination in UV Spectrophotometry. Int J Pharm Sci Res 2011, 3 (1), 236-240.

Singh, S.; Yadav, A. K.; Gautam, H. Simultaneous estimation of Valsartan and Hydrochlorothiazide in solid dosage form using UV Spectroscopy. Bull Pharm Res 2011, 1 (3), 10-12.

Swamy, T. G.; Nagaraju, N.; Rao, A. L. RP-HPLC Method for the simultaneous estimation of Telmisartan and Hydrochlorothiazide in pharmaceutical dosage form. Int J Drug Dev Res 2011, 3 (4), 362-368.

Redasani, V. K.; Patel, P. V.; Surana, S. J. Spectrophotometric method for simultaneous estimation of Valsartan and Hydrochlorthiazide in combined tablet dosage form. Der Pharm Sinica 2011, 2 (3), 123-130.

CDER. CBER, Guidance for Industry, Draft Guidance, Analytical Procedures and Methods Validation. In Chemistry, Manufacturing, and Controls Documentation, FDA 2000.

ICH. Guidelines: Text on validation of analytical procedures. In proceedings of International Conference on Harmonization Year, 1-5. Geneva, 1994



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