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Stability indicating RP- HPLC method for simultaneous estimation of telmisartan and hydrochlorothiazide

Journal: Pharmaceutical and Biological Evaluations (Vol.3, No. 4)

Publication Date:

Authors : ; ; ;

Page : 413-423

Keywords : Telmisartan; Hydrochlorothiazide; RP-HPLC; Stability indicating method;

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Abstract

Objective: Literature survey reveals that a lot of work has been carried out for the simultaneous estimation of Telmisartan and Hydrochloro-thiazide in combined dosage forms, but a very few work has been reported for the stability indicating assay for the above drugs. So looking at the potency, efficacy and market demand of the above drugs, it is obligatory to generate an inherent stability data for combination of Telmisartan and Hydrochlorothiazide through stress degradation studies under variety of ICH recommended test conditions and develop a simple, rapid, economic stability indicating assay method.Methods: Stability indicating RP-HPLC method for the assay of Telmisartan (TEL) and Hydrochlorothiazide (HTCZ) was developed by using C-18, 250 mm × 4.6 mm dimension with 0.5 ? particle size was developed. Methanol: Water =1:1 was selected as mobile phase wavelength of detection selected was 284 nm (iso-absorptive point of TEL and HTCZ).Results: Linearity was observed in the concentration range of 20 - 100 ?g/ml for TEL and HTCZ. The % recovery for TEL and HTCZ was found to be 99.92 ± 0.016 - 100.16 ± 0.08 and 100.05 ± 0.09 - 100.12 ± 0.05, respectively. The low % RSD indicated, the method was accurate and precise. Developed method was applied for the stability indicating assay of the drugs, for routine analysis.Conclusions: The simplicity, rapidity, reproducibility, and repeatability of the proposed methods completely fulfill the objective of the research work of simultaneous analysis of this drug combination. The results showed that Telmisartan was quite resistant to stress conditions, while Hydrochlorothiazide was comparatively unstable under stress conditions. The methods developed were found to be precise and accurate and could be used for routine work.

Last modified: 2016-08-23 00:57:26