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Abstract

DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE IN TABLET DOSAGE FORM BY RPHPLC

Govinda Rao Kamala*, Mrudula Devi K. and Pavani M.

ABSTRACT

An accurate and precise HPLC method was developed for the determination of Quinapril hydrochloride and Hydrochlorothiazide in tablet dosage form. The scope of the present work is to expand and optimization of the chromatographic conditions and to develop RPHPLC method. The method was performed with various mobile phases and columns, among various trials; Separation of the drug was achieved on ACE C18 (150×4.6) mm, 5μ using mobile phases, (A) 3.5 pH phosphate buffer, (B) Acetonitrile and Water in the ratio of 90:10v/v. The flow rate was 1.0 ml/min and the detection wavelength was 225 nm. Since it gave a good resolution and peak shapes with perfect optimization. The % RSD for the retention times and peak area of Quinapril HCl and Hydrochlorothiazide were found to be less than 2%. The correlation coefficient for linear curve obtained between concentration vs area for standard preparations of Quinapril HCl and Hydrochlorothiazide is 0.999. Precision was performed and % RSD for Quinapril hydrochloride and Hydrochlorothiazide were found to be less than 2.0. Three concentrations 50%, 100%, 150%, were injected in a triplicate manner and amount the % Recovery for each level should be between 100.17 % and 99.53% respectively. It is observed from the above data, diluent or excipient peaks were not interfering with the Quinapril HCl and Hydrochlorothiazide peaks. Test results for Quinapril HCl and Hydrochlorothiazide of LOD and LOQ were within limits. Hence, the chromatographic method developed for Quinapril hydrochloride and Hydrochlorothiazide is said to be rapid, simple, specific, sensitive, precise, accurate and reliable that can be effectively applied for routine analysis in research institutions, quality control department in industries, approved testing laboratories, bio-pharmaceutics and bio-equivalence studies and in clinical pharmacokinetic studies.

Keywords: Quinapril hydrochloride, Hydrochlorothiazide, Optimization method validation, RP-HPLC.


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