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Maitreyi N. Zaveri , Amit Khandhar

Abstract

The reverse phase high performance liquid chromatography (RP-HPLC) method of Atenolol and Hydrochlorothiazide is individually available in United State of Pharmacopoeia-27 (USP-27) but no reference is available for combined estimation of Atenolol and Hydrochlorothiazide in tablets formulation. The aim of our present work was to develop a precise and validated RP-HPLC method for the simultaneous determination of Atenolol and Hydrochlorothiazide in tablets formulation. The quantification was carried out by using Zorbax SB-CN (250 x 4.6 mm), 5μm column in isocratic mode with mobile phase, Water: Buffer: Methanol (50:35:15). The flow rate was 1.2 ml/min. The peak purity of Atenolol and Hydrochlorothiazide were 0.999 and 1.000 respectively. Ruggedness and robustness of method were performed and the percentage relative standard deviation (RSD) was found below 2.0%. The percentage recovery was found in the range of 98% to 102% at three different levels. Calibration curves were linear over studies ranges with correlation co-efficient found between the range of 0.99 to 1.00. Sample and standard solution stability study was performed over 21 h at room temperature and found stable. The percentage deviation was below 2.0%.

Keywords

Atenolol, Hydrochlorothiazide, RP - HPLC Method, Combination Tablets.

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Maitreyi Zaveri , Amit Khandhar

Abstract

The objective of this prese nt work was to develop and validate analytical method for quantitative determination of Paracetamol and Etoricoxib in a tablet formulation and also the comparison of invitro data with reference dosage form. Chromatographic separations of the two drugs were analyzed on a Kromasil C18 column (25cm X 4.6mm, 5 μm). The mobile phase constituted of Buffer: Acetonitirile with gradient program was delivered at the flow rate 1.0 mL/min. Detection was performed at 220 nm. Separation was completed within 20 min. Calibr ation curves were linear with coefficient correlation between 0.99 to 1.0 over a concentration range of 48 to 146 μg/mL of Paracetamol and 6 to 19 μg/mL for Etoricoxib respectively. The relative standard deviation (R.S.D) was found to be less than 2.0%. An alysis for dissolution study was also performed by Reversed - Phase High Performance Liquid Chromatography (RP - HPLC) method. Difference factor (f ₁) were found to be 2.85 and 3.83 and similarity factor (f₂) were found to be 73.514 and 68.961 for Paracetamol a nd Etoricoxib respectively.

Keywords

Paracetamol, Etoricoxib, RP - HPLC, In - Vitro, Dissolution, HPLC, COX2.

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