LC Determination of Lercanidipine and Its Impurities Using Drylab Software and Experimental Design Procedures

Popović, Igor; Ivanović, Darko; Medenica, Mirjana; Malenović, Anđelija; Jančić–Stojanović, Biljana

doi:10.1365/s10337-008-0536-3

Cited by 14 publications

(11 citation statements)

References 26 publications

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“…step 1 of the LC method development strategy described in the Introduction) established protocols for retention modelling and optimisation (i.e. step 2) were employed to develop robust LC methodologies [39][40][41][42][43][44][45]. Retention modelling and optimisation using the DryLab® software was performed with an UHPLC system capable of operating at 1,200 bar of pressure and possessing a low dwell volume and system dispersion volume suitable for use with rapid column formats (i.e.…”

Section: Retention Modelling and Optimisationmentioning

confidence: 99%

Chromatographic retention behaviour, modelling and separation optimisation of the quaternary ammonium salt isometamidium chloride and related compounds on a range of reversed-phase liquid chromatographic stationary phases

Schad

Euerby²,

Skellern

et al. 2012

Anal Bioanal Chem

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This paper describes the reversed-phase liquid chromatographic behaviour of the trypanocidal quaternary ammonium salt isometamidium chloride and its related compounds on a range of liquid chromatographic phases possessing alkyl and phenyl ligands on the same inert silica. In a parallel study with various extended polar selectivity phases which possessed different hydrophobic/silanophilic (hydrogen bonding) activity ratios, the chromatographic retention/selectivities of the quaternary ammonium salts was shown to be due to a co-operative mechanism between hydrophobic and silanophilic interactions. The highly aromatic and planar isometamidium compounds were found to be substantially retained on stationary phases containing aromatic functionality via strong π-π interactions. The chemometric approach of principal component analysis was used to characterise the chromatographic behaviour of the isometamidium compounds on the differing phases and to help identify the dominant retention mechanism(s). Two-dimensional (temperature/gradient) retention modelling was employed to develop and optimise a rapid liquid chromatography method for the separation of the six quaternary ammonium salts within 2.5 min which would be suitable for bioanalysis using liquid chromatography-mass spectrometry. This is the first reported systematic study of the relationship between stationary phase chemistries and retention/selectivity for a group of quaternary ammonium salts.

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Section: Retention Modelling and Optimisationmentioning

confidence: 99%

Chromatographic retention behaviour, modelling and separation optimisation of the quaternary ammonium salt isometamidium chloride and related compounds on a range of reversed-phase liquid chromatographic stationary phases

Schad

Euerby²,

Skellern

et al. 2012

Anal Bioanal Chem

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show abstract

“…Liquid chromatographic method development can be a long and time-consuming procedure because can be repeated many times throughout a drug development timeline [3,4]. Methods are commonly developed using one-factor-at-a-time (OFAT) approach in which one variable is changed sequentially until a suitable method is produced.…”

Section: Introductionmentioning

confidence: 99%

Application of Quality by Design for Development and Validation of RP-HPLC Method for Lercanidipine Hydrochloride

Bonde¹,

Bonde²,

Gawad³

2017

Asian J. Chem.

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Current research deals with the development of accurate, precise and robust analytical liquid chromatographic method for lercanidipine hydrochloride by application of quality by design (QbD). The key objective of research was to monitor the factors affecting the quality of analysis and also to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Basic process parameters which have the most impact on method performance were defined as proportion of acetonitrile in the mobile phase, pH of the aqueous phase and the flow rate. Quality by design (QbD) approach provided quantitative process knowledge which can be used to identify the HPLC instrument parameter settings that provided optimum chromatographic performance. The method optimization was accomplished using Fusion AE TM software (SMatrix Corporation, Eureka, CA) in 2 phases. In Phase 1, rapid screening was done to reduce the number of independent variables followed by phase II where the method was optimized using a DOE approach. Response surface design was implemented for experimental robustness testing and the method is validated to verify the adequacy of selected ideal chromatographic conditions: the analytical column of phenomenex C18 (250 mm × 4.6 mm, 5 µm particle size), mobile phase consist of acetonitrile-aqueous phase (10 mM phosphate buffer, pH adjusted to 4.5, (Gradient, organic phase 82 to 95 % v/v), pump flow rate 1.2 mL/min, and wavelength of detection 236 nm. The quality by design (QbD) based method development helped in better understanding of the overall method capabilities and limitations and ensured a greater chance of effective method validation.

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“…For LER various analytical methods have been reported for its individual estimation and in combined dosage form which includes HPLC, electrophoresis, LC-MS, extractive spectrophotometry, visible spectrophotometry, HPLC with electrochemical detection. [9][10][11][12][13][14][15] Two methods have been reported for simultaneous analysis of ATE and LER in its combination which include TLC-Densitometry and second order derivative spectrophotometry [16][17] . Here an attempt has been made to develop simple, rapid and accurate area under curve and absorption corrected spectroscopic methods [18][19] for simultaneous estimation of ATE and LER from its formulation.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Spectrophotometric Estimation of Atenolol and Lercanidipine Hydrochloride in Combined Dosage Form

Rashmi¹,

Sayali²,

Vishnu³

et al. 2010

Journal of Pharmaceutical Research

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Two simple, rapid, accurate and economic spectrophotometric methods have been developed for the determination of Atenolol (ATE) & Lercanidipine Hydrochloride (LER) in combined dosage form. The first method is Area under curve (AUC) and second is Absorption Corrected method. The wavelength ranges 260-264 & 280-285 were selected to determine Atenolol (ATE) & Lercanidipine (LER), respectively in combined formulation by AUC method. The second method was absorption corrected method in which both the drugs exhibited strong absorbance at 270.33 nm. However, LER exhibited strong absorbance at 353.93, at which ATE showed zero absorbance. Hence, 353.93 nm was selected as one wavelength for determination of LER without interference from ATE. Quantitative estimation of ATE was carried out by subtracting the absorption due to LER at 270.33 nm using experimentally calculated absorption factor. Beer's law was obeyed in the concentration range of 25-300 ì g/ml for ATE and 5-60 ì g/ml for LER for both the methods. The results of analysis have been validated statistically and recovery studies confirmed the accuracy and reproducibility of the proposed methods which were carried out by following ICH guidelines.

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LC Determination of Lercanidipine and Its Impurities Using Drylab Software and Experimental Design Procedures

Cited by 14 publications

References 26 publications

Chromatographic retention behaviour, modelling and separation optimisation of the quaternary ammonium salt isometamidium chloride and related compounds on a range of reversed-phase liquid chromatographic stationary phases

Chromatographic retention behaviour, modelling and separation optimisation of the quaternary ammonium salt isometamidium chloride and related compounds on a range of reversed-phase liquid chromatographic stationary phases

Application of Quality by Design for Development and Validation of RP-HPLC Method for Lercanidipine Hydrochloride

Simultaneous Spectrophotometric Estimation of Atenolol and Lercanidipine Hydrochloride in Combined Dosage Form

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