Analytical Quality-By-Design Compliant Ultrafast Liquid Chromatographic Method for Determination of Paliperidone in Extended Release Tablet Dosage Form

Panda, Sagar Suman

doi:10.4172/1948-593x.1000133

Cited by 10 publications

(2 citation statements)

References 19 publications

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“…Besides, it primarily facilitates rational understanding by establishing the cause-effect relationship between the quality attributes. Currently, QbD is extensively explored by analytical scientists for developing high-quality analytical methods [10][11][12]. QbD with respect to analytical methodology initiates with instituting the analytical target profile (ATP) and critical analytical attributes (CAAs), prioritizing followed by optimizing the critical method variables (CMVs) using an experimental design, followed by response surface analysis and desirability function to embark upon the optimal [13].…”

Section: Introductionmentioning

confidence: 99%

Ultrafast Liquid Chromatographic Estimation of Sertaconazole Nitrate in Pharmaceuticals Using Analytical Quality by Design

2019

MJAS

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An analytical Quality by Design(AQbD) oriented ultra-fast liquid chromatography method was developed for quantification of sertaconazole nitrate in pharmaceutical dosage form. A central composite design (CCD) was employed to establish optimum chromatographic conditions ensuring method robustness by selecting methanol (%) and flow rate (mL/min) as the factors, to study their effect on the system suitability parameters such as retention time, plate number and tailing factor as the response variable. Further, the method was carried out with design of experiments (DoE) optimized chromatographic conditions. The intermediate precision of the method was studied using a full factorial design (FFD) considering the number of days and analysts as the variables. The chromatographic separation was achieved on a phenyl-hexyl column using methanol: water (92:8, %v/v) as the mobile phase at a flow rate of 1.3 mL/min and photo diode array detection at 260 nm. The values obtained for validation parameters were within the acceptance limit. The method was linear over 5-100 µg/mL of sertaconazole. Analysis of the system suitability suggested a high degree of method reproducibility and robustness. In a nutshell, the method was found to be highly suitable for its applicability in the determination of sertaconazole in bulk and tablet dosage form. AbstrakReka bentuk kualiti analitikal berasaskan kaedah kromatografi cecair ultra-laju telah dibangunkan untuk pengkuantitian sertaconazole nitrat dalam bentuk dos farmaseutikal. Reka bentuk komposit berpusat (CCD) telah dibangunkan untuk mengoptimumkan keadaan kromatografi dalam memastikan keteguhan kaedahnya dengan memilih metanol (%) dan kadar aliran (mL/min) sebagai faktor, untuk menkaji kesannya terhadap sistem kesesuaian parameter seperti masa tahanan, nombor plat dan faktor pengekoran sebagai respons pembolehubah. Selanjutnya, kaedah diuji dengan reka bentuk eksperimen (DoE) yang telah dioptimumkan. Kepersisan pengantaraan kaedah telah dikaji dengan mengunakan reka bentuk berfaktor penuh (FFD) dengan bilangan hari dan ahli analisis diambil sebagai pembolehubah. Pemisahan kromatografi telah dicapai melalui turus fenil-heksi mengunakan metanol: air (92:8, %v/v) sebagai fasa bergerak pada kadar aliran 1.3 mL/min dan pengesanan susunan diod pada 260 nm. Nilai yang diperolehi untuk parameter validasi berada had yang dibenarkan. Kaedah adalah bersifat linear dari julat 5-100 µg/mL sertaconazole. Analisis kesesuaian sistem mencadangkan keteguhan dan kebolehulangan kaedah adalah tinggi. Oleh demikian, kaedah yang diperolehi adalah sesuai untuk aplikasi penentuan sertaconazole di dalam dos tablet dan pukal.

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Section: Introductionmentioning

confidence: 99%

Ultrafast Liquid Chromatographic Estimation of Sertaconazole Nitrate in Pharmaceuticals Using Analytical Quality by Design

2019

MJAS

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“…Even though International Conference on Harmonization (ICH Q8 R2) guidelines do not discuss analytical method development in correlation with design space, it is implicit that the concept can be utilized to analytical design space and continuous improvement in method understanding [1] . A number of excellent articles appeared in the literature [2][3][4][5][6][7][8] that described strategies for the application of QbD principles to chromatographic method development. The work presented in this article addressed key steps of AQbD with special focus on method optimization.…”

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confidence: 99%

Uncovering interaction by QbD in Optimization of Stability-indicating HPLC Method for Simultaneous Estimation of Low Dose Aspirin and Lansoprazole

Fanse¹,

Baghel²,

Rajput³

2016

pharmaceutical-sciences

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Fanse, et al.: Stability-indicating HPLC Method for Aspirin and LansoprazoleIn the present study a quality by design acquiescent method utilizing design of experiment and method operable design regions methodology was evaluated for optimization of chromatographic condition for separation of ten degradation products along with peaks of aspirin and lansoprazole. Box-Behnken design was exploited to evaluate the main and interaction effects of the selected critical process parameters on the critical quality attributes, viz resolution between the peak pairs and retention time of last eluting peak. The optimal separation was predicted at pH 3.6, with a gradient starting at 20% of acetonitrile and initial hold time of 10 min. The results of experimental methods show excellent agreement with predicted results, highlighting the importance of design of experiments in method optimization. The selected working condition was then fully validated according to International Conference on Harmonisation guidelines for linearity, range, accuracy, precision and robustness.

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Designer Foods: Scope for Enrichment With Microbe-Sourced Antioxidants

Sarethy

Pan

2017

Microbial Production of Food Ingredients and Additives

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Analytical Quality-By-Design Compliant Ultrafast Liquid Chromatographic Method for Determination of Paliperidone in Extended Release Tablet Dosage Form

Abstract: Determination of system suitability limits with a robustness test. J Chromatogr A 845: 145-154.

Cited by 10 publications

References 19 publications

Ultrafast Liquid Chromatographic Estimation of Sertaconazole Nitrate in Pharmaceuticals Using Analytical Quality by Design

Ultrafast Liquid Chromatographic Estimation of Sertaconazole Nitrate in Pharmaceuticals Using Analytical Quality by Design

Uncovering interaction by QbD in Optimization of Stability-indicating HPLC Method for Simultaneous Estimation of Low Dose Aspirin and Lansoprazole

Designer Foods: Scope for Enrichment With Microbe-Sourced Antioxidants

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