Derivative spectrophotometric method for simultaneous determination of ezetimibe and simvastatin in combined tablets

Abstract

KEYWORDSThe introduced study portrays the development and validation of an effortless, speedy and selective first order derivative zero-crossing spectrophotometric method to estimate ezetimibe and simvastatin simultaneously in combined drug products over and above in the presence of ezetimibe alkaline degradation products. Ezetimibe and its alkaline degradates spectra showed zero-crossing point at 249 nm, so the amplitude at 249 nm could be used for calculating the concentration of simvastatin. While simvastatin and ezetimibe alkaline degradates spectra showed a zero-reading value at 261 nm, so ezetimibe could be determined by measuring the amplitude at 261 nm. Regression plots revealed good linear relationships in the concentration range 1-16 µg/mL with accuracy checked by conducting recovery studies; average recovery was 99.61 ± 1.183 and 100.47 ± 1.310 for ezetimibe and simvastatin, respectively. The suggested first derivative spectrophotometric method was successfully applied for the determination of the cited drugs in "Inegy 10/10, 10/20 and 10/40 tablets". Satisfactory results were obtained for the recovery of both drugs and were in good agreement with the labeled amounts. Method validation was estimated according to USP guidelines.

Development of Uv Spectrophotometric Methods and Validation for Estimation of Simvastatin in Bulk and Tablet Dosage Form by Absorbance Maxima and Area Under the Curve Method

“…Journal of Applied Pharmacy (ISSN 19204159); www.japharmacy.ca spectrophotometry [3-10, 18, 19], Derivative Ratio spectrophotometry [11][12][13], Stability Indicating RP-UPLC [15], Stability Indicating RP-HPLC [14][15][16][17] , RP-HPLC [19][20][21][22][23][24][25][26][27][28][29][30], Stability indicating HPTLC [31], HPTLC [32][33][34] and LC-MS/MS [35] alone or in combination with other drugs. Two official methods utilizing HPLC Gradient methodology are reported in European Pharmacopoeia (EP) [36] United State Pharmacopoeia (USP) [37].…”

Spectrophotometric determination of 3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors in pharmaceutical preparations

“…The developed methods were based on a charge transfer reaction with TCNQ reagent. The proposed methods are nearly the same 11,16,18 or more sensitive 10,12−15,19 and time saving 9,13,14 than other published spectrophotometric methods. Moreover, the proposed methods are less expensive than the application of HPLC techniques.…”

TLC- Densitometric Method for Determination of some Cholesterol Lowering Drugs in Different Combinations

“…EZ and AT have been determined by some techniques including HPLC [18], HPTLC-Densitometric [19] and spectrophotometric methods [20]. On the other hand EZ and SIM have been determined in their association by HPLC [21][22][23], HPTLC-Densitometric [24] and spectrophotometric methods [25].…”