Malaysian Journal of Analytical Sciences Vol 23 No 2 (2019): 312 - 324

ULTRAFAST LIQUID CHROMATOGRAPHIC ESTIMATION OF SERTACONAZOLE NITRATE IN PHARMACEUTICALS USING ANALYTICAL QUALITY BY DESIGN

(Kromatografi Cecair Ultra-laju bagi Anggaran Sertaconazole Nitrat dalam Farmaseutikal Menggunakan Reka Bentuk Kualiti Analitikal)

Sagar Suman Panda*, Venkata Varaha Ravi Kumar Bera, Rakeya Samanta

Department of Pharmaceutical Analysis and Quality Assurance,

Roland Institute of Pharmaceutical Sciences (Affiliated to Biju Patnaik University of Technology, Odisha),
Khodasingi, Berhampur-760010, Odisha, India

*Corresponding author: sagarguddu2002@gmail.com

Received: 24 May 2018; Accepted: 24 February 2019

Abstract

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.

Keywords: sertaconazole, ultrafast liquid chromatography, quality by design, design of experiments, robustness

Abstrak

Reka 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.

Kata kunci:  sertaconazole, kromatografi cecair ultra-laju, kualiti reka bentuk, reka bentuk eksperimen, keteguhan

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