Identification of degradation impurities in aripiprazole oral solution using LC–MS and development of validated stability indicating method for assay and content of two preservatives by RP-HPLC

Krishna, M.Vamsi; Rao, Sumathi V.; Venugopal, N. V. S.

doi:10.1080/10826076.2017.1357572

Cited by 11 publications

(6 citation statements)

References 14 publications

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“…14 The literature survey revealed that HPLC methods were dominantly developed for the separation of AR and its known impurities. [13][14][15][16][17][18][19][20] It was noticed that octyl (C8) or octadecyl (C18) are the most commonly applied stationary phases. Unfortunately, in all these methods, the overall quality of the chromatographic separations was not quite adequate, because either the peaks of IMP E and AR were significantly close to each other or/and IMP E eluted after the peak of the active pharmaceutical ingredient (API).…”

Section: A N U S C R I P Tmentioning

confidence: 99%

“…Unfortunately, in all these methods, the overall quality of the chromatographic separations was not quite adequate, because either the peaks of IMP E and AR were significantly close to each other or/and IMP E eluted after the peak of the active pharmaceutical ingredient (API). [13][14][15][16] In practice, with such elution, the tail of the API's peak may overlap with a much smaller peak of following impurity, which eventually occurs with long lifecycle methods and/or during problematic inter-laboratory analytical method transfer and consequently affects the impurity identification and quantification as well as the estimation of the overall AR quality. Therefore, separation conditions with different selectivity could be more beneficial.…”

Section: A N U S C R I P Tmentioning

confidence: 99%

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Optimization of chromatographic separation of aripiprazole and impurities: Quantitative structure-retention relationship approach

Svrkota

Krmar

Protić

et al. 2022

JSCS

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New optimization strategy based on mixed Quantitative Structure-Retention Relationship (QSRR) model was proposed for improving the RP-HPLC separation of aripiprazole and its impurities (IMP A-E). Firstly, experimental parameters (EPs) (mobile phase composition and flow rate) were varied according to Box-Behnken Design and afterwards, artificial neural network (ANN) as QSRR model was built correlating EPs and selected molecular descriptors (ovality, torsion energy and non-1,4-Van der Waals energy) with analytes log-transformed retention time. Values of root mean square error (RMSE) were used for ANNs quality estimation (0.0227, 0.0191 and 0.0230 for training, verification and test set, respectively). Separations of critical peak pairs on chromatogram (IMP A-B and IMP D-C) were optimized using ANNs for which EPs served as inputs and log-transformed separation criteria s as outputs. They were validated applying leave-one-out cross-validation (RMSE values 0.065 and 0.056, respectively). Obtained ANNs were used for plotting response surfaces upon which analyses chromatographic conditions resulting in optimal analytes retention behaviour and optimal values of separation criteria s were defined and they comprised of 54 % of methanol at the beginning and 79 % of methanol at the end of gradient elution programme with mobile phase flow rate of 460 ?L min-1.

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Section: A N U S C R I P Tmentioning

confidence: 99%

Section: A N U S C R I P Tmentioning

confidence: 99%

Optimization of chromatographic separation of aripiprazole and impurities: Quantitative structure-retention relationship approach

Svrkota

Krmar

Protić

et al. 2022

JSCS

View full text Add to dashboard Cite

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“…The hyphenated technique is a sophisticated, repeatable and flexible method for estimating analytes in a variety of biological and pharmaceutical samples. M. V. V. N. Murali Krishna et al [39] investigated degradation impurities in APZ oral solution using LC-MS method. Hui-Ching Huang et al [40] developed and validated a new method for detecting APZ and its main metabolite, dehydro aripiprazole, in plasma using gas chromatography-mass spectrometry (GC-MS).…”

Section: Hyphenated Techniquementioning

confidence: 99%

A Compact Analytical Profile of Aripiprazole: Analytical Methodologies

Athira¹,

Rishad²,

Babu

et al. 2021

JPRI

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Aripiprazole (APZ) is an antipsychotic drug that belongs to benzisoxazole derivatives and is used to treat schizophrenia as well as acute manic or mixed effects in patients with bipolar 1 disorder. APZ is used to treat certain mental, mood disorders such as bipolar disorder, Schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder. It may also be used in combination with other medication to treat depression. The present review article would be useful for prospective studies for researchers interested in APZ formulation production and quality management. Using a thorough computer assisted literature survey; this review touches upon the various reported analytical methods for the quantification of APZ both in API (Active Pharmaceutical Ingredient) and pharmaceutical dosage forms. The present write-up also encompasses the various published research articles like Spectroscopy techniques, X- Ray Diffraction (XRD), Electro Chemical Technique, Differential Scanning Calorimeter (DSC) and Capillary Electrophoresis. This is the first review article in this series with focus on the analytical profile of APZ. Although, several methods were reported in the literature, HPLC stands out first for the quantification of APZ.

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“…Several stability indicating RP‐HPLC–UV [3–10], LC‐QToF [11], and LC–MS methods [12] are reported. However, some of them are just presenting determination of aripiprazole in the presence of degradation products formed in the forced degradation studies [3–5], while the others have selected impurities that are not degradation products at all and thus inadequate to attain stated aim [6–11].…”

Section: Introductionmentioning

confidence: 99%

“…Although Krishna et al. [12] have subjected stress samples to LC–MS in ESI+ mode and identified major degradation products, they have also presented merely determination of aripiprazole in the presence of its degradation products. For the determination of aripiprazole and its nine impurities gradient RP‐HPLC method with acetonitrile, phosphate buffer pH 3.0, and ion‐pairing agent sodium pentanesulfonate in the mobile phase was developed and validated [13].…”

Section: Introductionmentioning

confidence: 99%

Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles

Rmandić

Malenović

2020

J of Separation Science

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In this paper, development of robust and reliable chaotropic chromatography method for the determination of aripiprazole and its impurities, following Analytical Quality by Design principles is presented. The efficient baseline separation and accurate determination of aripiprazole and its four impurities from tablets were set as Analytical Target Profile. In line with it, the influence of Critical Method Parameters (acetonitrile content, concentration of perchloric acid in water phase, and column temperature) on predefined Critical Method Attributes (separation of the critical pair of peaks, retention of the first and last eluting peak) was investigated with aid of the Central Composite Design. Further on Design Space, where Critical Method Parameters meet predefined acceptance limits with a high level of probability (π ≥ 85%), was computed as a result of performed Monte Carlo simulations. A normal operating conditions corresponding to 34% of acetonitrile, 66% of 42.5 mM perchloric acid, and column temperature at 35°C were selected from created Design Space. Robustness testing of the quantitative performances of the developed method was conducted combining Plackett–Burman design with alias matrix approach. Through the additional validation testing, reliability of the developed method for the use in the routine practice was completely confirmed.

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Identification of degradation impurities in aripiprazole oral solution using LC–MS and development of validated stability indicating method for assay and content of two preservatives by RP-HPLC

Cited by 11 publications

References 14 publications

Optimization of chromatographic separation of aripiprazole and impurities: Quantitative structure-retention relationship approach

Optimization of chromatographic separation of aripiprazole and impurities: Quantitative structure-retention relationship approach

A Compact Analytical Profile of Aripiprazole: Analytical Methodologies

Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles

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