Determination of lisinopril using anion exchange chromatography with integrated pulsed amperometric detection

Liu, Yu Xiu; Shou, Dan; Chen, Mei Lan; Chen, Zhidong; Zhang, Pei Min; Zhu, Yan

doi:10.1016/j.cclet.2011.11.024

Cited by 8 publications

(3 citation statements)

References 13 publications

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“…The European Pharmacopoeia recommends quantification of API in the pure substance of lisinopril dihydrate using alkalimetry with potentiometric indication of equivalence point [5]. Numerous chromatographic methods for the determination of lisinopril in pure substance, dosage forms and biological fluids, including HPLC [6][7][8][9][10], ion-exchange chromatography with amperometric detection [11] and capillary electrophoresis [12] have been presented in the literature. Voltammetric [13], polarographic [14] and spectrofluorimetric methods for the determination of lisinopril [15] have also been described.…”

Section: Development Of Spectrophotometric Methods For Determination ...mentioning

confidence: 99%

“…ªâðîïåéñüêà Ôàðìàêîïåÿ ðåêîìåíäóº çä³éñíþâàòè ê³ëüê³ñíå âèçíà÷åííÿ ÀÔ² â ñóá-ñòàíö³¿ ë³çèíîïðèëó äèã³äðàòó àëêàë³ìåòðè÷íî ç ïîòåíö³îìåòðè÷íîþ ³íäèêàö³ºþ òî÷êè åê-â³âàëåíòíîñò³ [5]. Ó äaeåðåëàõ ë³òåðàòóðè íà-âåäåí³ ÷èñëåíí³ õðîìàòîãðàô³÷í³ ìåòîäèêè âèçíà÷åííÿ ë³çèíîïðèëó ó ñóáñòàíö³¿, ë³êàðñüêèõ ôîðìàõ òà á³îëîã³÷íèõ ð³äèíàõ, çîêðåìà ÂÅÐÕ [6][7][8][9][10], ³îíîîáì³ííà õðîìàòîãðàô³ÿ ç àì-ïåðîìåòðè÷íèì äåòåêòóâàííÿì [11] òà êàï³ëÿðíèé åëåêòðîôîðåç [12]. Îïèñàí³ òàêîae âî-ëüòàìïåðîìåòðè÷í³ [13], ïîëÿðîãðàô³÷í³ [14] òà ñïåêòðîôëóîðèìåòðè÷í³ ìåòîäèêè âèçíà-÷åííÿ ë³çèíîïðèëó [15].…”

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Development of Spectrophotometric Method for Determination of Lisinopril in Tablet Dosage Form

Shulyak

Budzivula

Kryskiw

et al. 2022

AML

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Aim. The research aims at developing a fast, simple, reliable spectrophotometric method according to "green" chemistry principles for the determination of lisinopril in pure substance and in drugs presented on the Ukrainian market. Materials and Methods. Chemical reference standard of lisinopril dihydrate (Sigma-Aldrich, ³98%, HPLC), methanol R (Honeywell Riedel-de Haen™, 99.9%), tablets of Lisinopril-Astrapharm 10 mg), Lisinopril-KRKA 10 mg (Slovenia) and Lisinopril-Teva 10 mg (Germany) were used in this study. Double-beam scanning spectrophotometer "Shimadzu UV-1800" (Japan) connected with software package UV-Probe 2.62 were used for measurements. Absorbance of the solutions in the UV region were recorded in 1 cm quartz cells vs. methanol R. Laboratory electronic balance RAD WAG AS 200 / C, ultrasonic bath Sonorex Digitec DT100H and measuring glassware of grade A were used. Statistical processing and determination of validation parameters were performed in accordance with the requirements of State Pharmacopoeia of Ukraine 2.0 and ICH Q2. Results and Discussions. The spectrophotometric method for the determination of lisinopril by direct measurement of the absorbance of the tested solutions in the ultraviolet region of the spectrum has been developed (lmax=212 nm). Validation parameters including linearity, range of application, specificity, accuracy, precision, limit of detection and limit of quantification, robustness were calculated for the proposed analytical procedure. The correctness of the analytical method was proved by calculating the complete uncertainty of the latter. The calculated uncertainty of sample preparation (DSP) for the determination of lisinopril in tablets was 2.46%. It was established that the maximum contribution to the uncertainty of sample preparation for operations of the quantification of lisinopril in tablets, make the operations of lisinopril CRS sampling and aliquots pipetting. The total uncertainty of the analytical procedure (DAs) in the analysis of the drug was 2.56%. The predicted complete uncertainty of the analysis results did not exceed critical values (DAs=2.56 % £ maxDAs=3.2 %), the method is correct. The specificity is proved by the absence of interfering influence of excipients due to nonoccurence of absorption at the analytical wavelength in the analysis of methanolic extract of placebo-tested tablets, Beers law was obeyed in the ranges of 20-100 mg / ml. The least squares method was used for statistical processing of the results. Regression analysis yielded the following calibration equation: y=26,791x-0,4398. The limit of detection and the limit of quantification were 2,3 і 6,9 mg/ml. Robustness of the method was estimated by studying of absorbance stability changes of tested solutions over time. Robustness was assessed by studying the absorbance stability of the tested solutions over time. It was found that freshly prepared solutions should be used within 100 min. Developed procedure for lisinopril determination in pure substance and tablet dosage form proved to be an excellent green analysis according to analytical eco-scale. Conclusions. Fast, simple, reliable, cost-effective, in accordance with the principles of "green" chemistry spectrophotometric method for determination of lisinopril in pure substance and tablets has been proposed. Validation of the analytical procedure on the parameters of linearity, application range, specificity, accuracy, precision, robustness, limit of detection and limit of quantification was carried out. The complete uncertainty of the analytical procedure at the level of 2.56% was obtained, which proves the possibility of obtaining correct analysis results in other laboratories.

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Section: Development Of Spectrophotometric Methods For Determination ...mentioning

confidence: 99%

unclassified

Development of Spectrophotometric Method for Determination of Lisinopril in Tablet Dosage Form

Shulyak

Budzivula

Kryskiw

et al. 2022

AML

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“…When ACE inhibitors are used at the same time, activation of the renin-angiotensin system is prevented, enhancing the effect of both therapies and decreasing their side effects as lower doses are needed [2,3]. LIS was previously analyzed by titrimetric [4], spectrophotometric [5][6][7][8][9][10][11][12][13][14], Spectrofluorimetric [15][16][17][18][19], chromatographic [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38], electrophoretic [39,40] and electrochemical methods [4,41,42]. Mixtures of LIS and HCT were analyzed simultaneously by spectrophotometric [43][44][45], chromatographic [21,22,29,<...>…”

Section: Introductionmentioning

confidence: 99%

Two smart spectrophotometric methods for simultaneous determination of Lisinopril and Hydrochlorothiazide in binary mixtures

Mohammed

El-Din

Derayea

2019

Journal of advanced Biomedical and Pharmaceutical Sciences

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Two new, simple, fast and sensitive spectrophotometric methods were developed for analysis of binary mixtures of Lisinopril (LIS) and hydrochlorothiazide (HCT). These methods were absorptivity factor method and ratio subtraction method. In the first method, calculations were made using the absorbance of the mixtures at 211 nm where LIS absorptivity is half HCT absorptivity. On the other hand, the second method was based on obtaining the original spectrum of LIS from the zero order spectrum of the binary mixture then determining the concentration of LIS from its linear regression equation. HCT concentration in both methods was determined from the absorbance at 270 nm where a lack of interference of LIS occurs. The methods were validated according to ICH and applied successfully on different ratios of laboratory mixtures and on pharmaceutical tablets with excellent accuracy and precision.

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Selective spectrofluorimetric method for determination of Lisinopril in pharmaceutical preparations and in presence of hydrochlorothiazide: Application to content uniformity testing

2017

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A novel sensitive and cost-effective spectrofluorimetric method has been developed and validated for determination of lisinopril (an angiotensin converting enzyme inhibitor) in its pure form and pharmaceutical preparations. The method is based on the reaction of the drug with ninhydrin and phenylacetaldehyde in buffered medium (pH 7.0) to form a highly fluorescent product measured at 460 nm after excitation at 390 nm. Different experimental parameters were optimized and calibration curve was constructed. The fluorescence-concentration relationship was linear in the range of 0.15-4.0 μg mL . The calculated Limit of detection (LOD) and Limit of quantitation (LOQ) were 0.04 and 0.12 μg mL , respectively. The method was successfully applied for the analysis of pharmaceutical preparations containing the studied drug either alone or co-formulated with hydrochlorothiazide. The obtained results were in agreement with those of the reported method in respect to accuracy and precession. Moreover, the method was applied content uniformity testing according to United States Pharmacopeia (USP) guidelines.

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Determination of lisinopril using anion exchange chromatography with integrated pulsed amperometric detection

Cited by 8 publications

References 13 publications

Development of Spectrophotometric Method for Determination of Lisinopril in Tablet Dosage Form

Development of Spectrophotometric Method for Determination of Lisinopril in Tablet Dosage Form

Two smart spectrophotometric methods for simultaneous determination of Lisinopril and Hydrochlorothiazide in binary mixtures

Selective spectrofluorimetric method for determination of Lisinopril in pharmaceutical preparations and in presence of hydrochlorothiazide: Application to content uniformity testing

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