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Title : ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDE IN TABLET DOSAGE FORM BY RP-HPLC
Authors : K. Priyanka, A. Ajitha, M. Sandhya Mamindla, V. Uma Maheswara Rao
Abstract : A simple, precise, rapid, specific and accurate reverse phase high performance liquid chromatography method was developed for simultaneous estimation of Fosinopril Sodium (FOS) and Hydrochlorothiazide (HCTZ) in pharmaceutical dosage form. Chromatographic separation was performed on X-terra(C8) (4.6mm x 150mm, 3.5m) column, with mobile phase comprising of mixture of buffer (pH 6.0, adjusted with ortho phosphoric acid), acetonitrile and methanol&nbsp; in the ratio of 80:10:10v/v, at the flow rate 0.8 ml/min. The detection was carried out at 226 nm. The retention times of FOS and HCTZ were found to be 2.1 and 3.3 mins respectively with a run time of 6 mins, theoretical levels for FOS and HCTZ were 2015 and 4034 respectively, with a resolution of 5.42. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation, robustness and ruggedness. Linearity of FOS was found in the range of 10-50 &micro;g/mL and that for HCTZ was found to be 6.25-31.35 &micro;g/mL. The correlation coefficient for FOS and HCTZ were 0.9992 and 0.9991 respectively. The LOD values for FOS and HCTZ were 0.88 and 1.11 &micro;g/mL respectively. The LOQ values for FOS and HCTZ were and 2.96 and 3.7 &micro;g/mL respectively. This demonstrates that the developed method is simple, precise, rapid, selective, accurate and reproducible for simultaneous estimation of FOS and HCTZ tablet dosage form.<br />

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