Validated Chromatographic Methods for Determination of Perindopril and Amlodipine in Pharmaceutical Formulation in the Presence of their Degradation Products

Abstract

Two specific, sensitive, and precise stability-indicating chromatographic methods have been developed, optimized and validated for determination of perindopril arginin (PER) and amlodipine besylate (AML) in their mixtures and in the presence of their degradation products. The first method was based on thin-layer chromatography (TLC) combined with densitometric determination of the separated bands. Adequate separation was achieved using silica gel 60 F254 TLC plates and ethyl acetate-methanol-toluene-ammonia solution, 33% (6.5:2:1:0.5 by volume), as a developing system. The second method was based on high-performance liquid chromatography, by which the proposed components were separated on a reversed-phase C18 analytical column using a mobile phase consisting of phosphate buffer (pH 2.5, 0.01 M)-acetonitrile-tetrahydrofuran (60:40:0.1% by volume) with ultraviolet detection at 218 nm. Different parameters affecting the suggested methods were optimized for maximum separation of the cited components. System suitability parameters of the two developed methods were also tested. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for the quantification of PER and AML in their commercial tablets. Both methods were also statistically compared to each other and to the reference methods with no significant differences in performance.

Advanced Amplitude Centering as an Invigorating Manipulation for Unified Wavelength Spectral Resolution of Ternary Mixtures

“…or (ΔP = { }) of different concentrations of pure X at λ1 and λ3 versus the corresponding ratio amplitude of Y or X at λ1 2 1 P P − this can be summarized as follows: The postulated amplitude value which corresponding to component Y or X in the mixture (P(Y) postulated ) or (P(x) postulated ) was obtained by substitution in previously computed regression equations using amplitude difference between two wavelengths (λ1 andλ2) in case of Y Eq (10) or (λ1 andλ3) in case of X Eq (11), where the constant Z/Zʹ will be cancelled along with those corresponding to X or Y respectively which show two equal amplitudes at these chosen two wavelengths.…”

“…The components of interest were amlodipine (AML), valsartan (VAL) and hydrochlorothiazide (HCT). Several analytical techniques, including chromatography, spectrophotometry and electrochemistry, were reported for the analysis of each the components individually: AML [8][9][10][11][12] , VAL [13][14][15][16] and HCT [17][18][19] The binary mixture of AML and VAL was determined using spectrophotometric [20] and HPLC methods [21] while the mixture containing AML and HCT was determined using spectrophotometric method [22] and capillary electrophoresis [23] The binary mixture of VAL and HCT was determined using spectroscopic, TLC and HPLC methods [24].…”

Novel ratio difference at coabsorptive point spectrophotometric method for determination of components with wide variation in their absorptivities

“…Although PA and AM have been analyzed by three methods in their binary mixtures by TLC [6,7] and HPLC [6][7][8], none of the reported methods have been described spectrophotometric method for the simultaneous determination of PA and AM in tablet dosage form. Therefore, the objective of this work is to develop a novel spectrophotometric method namely; Ratio Difference at Coabsorptive points (RDC) for selective determination of PA and AM in their binary mixture.…”

Selective spectrofluorimetric method for the determination of perindopril erbumine in bulk and tablets through derivatization with dansyl chloride

“…Literature reported only few analytical methods for the determination of PDE in its bulk, dosage forms and human plasma, such as high performance liquid chromatography (Raju and Rao 2011;Zaazaa et al 2013;Riyaz et al 2012;Chaudhary et al 2010;Jogia et al 2010;Joseph et al 2011;Prajapati et al 2011a), HPLC-MS (Jaina et al 2006 andNirogi et al 2006), high performance thin layer chromatography (Dewani et al 2011), and spectrophotometry (Neelam et al 2012;Rahman et al 2012;Prajapati et al 2011b). However, the chromatographic methods were found to have certain drawbacks, such as the expensive instrumentation and high analysis cost.…”