ANALYSIS OF CARVEDILOL AND SPIRONOLACTONE IN PHARMACEUTICAL DOSAGE FORM AND DISSOLUTION SAMPLES BY SIMULTANEOUS EQUATION METHOD AND DERIVATIVE METHOD

Puravi Kundu, Nihar Ranjan Pani, Abhisek Barik, Bibaswan Mishra

Abstract


Two spectroscopic methods such as simultaneous equation method and third order derivative spectroscopic method for the simultaneous estimation of carvedilol (CARV) and spironolactone (SPRN) in pharmaceutical dosage form and dissolution samples were developed. The methods were validated as per the ICH guidelines for different parameters such as linearity, .specificity, accuracy, precission, limit of detection and limit of quantification. The equal concentration of both drugs (10 µg/ml) solutions were scanned separately in the UV-region and from the overlain spectra, two wavelengths, 243 nm (λmax of CARV) and 236 nm (λmax of SPRN) were selected for the formation of simultaneous equation (method I). The zero order spectrum was processed to obtain third-derivative spectrum (method II).  The two third derivative spectra were overlaid which shows that CARV showed zero crossing point (ZCP) at 257.2 nm, while SPRN showed ZCP at 308.6 nm. The determinations were made at 308.6 nm for CARV (ZCP of SPRN) and 257.2 nm for SPRN (ZCP of CARV).  Linear relationship was found in the concentration range of 5-30µg/mL for CARV and SPRN by both methods. Both methods were found accurate and precise. The bilayer tablet (in house) was analyzed and amount of CARV and SPRN determined by the proposed method was found to be 99.52 % for CARV and 99.74 % for SPRN, respectively by simultaneous equation method and 99.04 % for CARV and 98.28 % for SPRN by employing third derivative spectroscopic method. The described methods are giving accurate and precise results for the determination of carvedilol and spiranolactone mixture in formulations. The proposed methods could be satisfactorily employed in dissolution studies to determine the percentage drug release.

Keywords


Simultaneous equation, Derivative spectroscopic, Validation, Carvedilol and Spiranolactone

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