Validated Stability Indicating Method for Determination of Indapamide in Pharmaceutical Formulation

Abstract

A stability indicating method for Indapamide in an oral antihypertensive tablet and bulk dosage forms was developed and validated by reverse phase HPLC (RP-HPLC). The proposed RP-HPLC Shisheido Capcell Pak C18 column was used and column dimension was 250mm × 4.6mm i.d., 5μm partical size at ambient temperature. The mobile phase Methanol and Phosphate Buffer pH 5.8 (60:40) was run in isocratic mode at a flow rate of 1.0ml/minute. The wavelength of Indapamide was selected at 241nm. Indapamide was found as single peak in the chromatogram at 6.58 min. The different chromatographic conditions were applied to determine the drug in pharmaceutical dosage form. The linearity of the proposed method was found in a range of 0.2-1.2μg/ml with coefficient of correlation (r2) value 0.999, slope 8360 and intercept -77.78. The percent RSD of intraday precision and interday precision were found in range of 0.498 - 1.661 and 0.882 - 1.623 respectively. The average accuracy of the method at three different levels of 50, 100 and 150 % were found to be 100.67, 99.50 and 100.65, respectively. The LOQ and LOD expressed as signal to noise ratio (S/N) were found to be 0.03 and 0.08μg/mL with good accuracy and precision. Indapamide was exposed to different stress conditions like alkaline, acidic, thermal, oxidative and photolytic. The stressed samples were analyzed by the proposed method. The proposed methods can be used for routine analysis stability testing and assay of Indapamide in quality control laboratories.