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Development of a stability-indicating UPLC method for determination of isotretinoin in bulk drug

Hsi, S-L, Surman, P and Al-Kassas, R (2018) Development of a stability-indicating UPLC method for determination of isotretinoin in bulk drug. Pharmaceutical Development and Technology, 24 (2). pp. 189-198. ISSN 1083-7450

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Abstract

A highly sensitive and rapid stability indicating ultra-performance liquid chromatographic (UPLC) method was developed for the quantification and identification of isotretinoin in bulk. Chromatographic separation was developed using a gradient elution in a reversed-phase system at flow rate of 0.5 ml/min with 12 min run time. The mobile phase was a gradient mixture of mobile phase A (contained a 30:70:0.5 mixture solution of methanol/purified water/glacial acetic acid) and mobile phase B (contained a 70:25:4.5:0.5 mixture solution of methanol/acetonitrile/purified water/glacial acetic acid). Eluents were monitored at 355 nm. The analytical method was validated for accuracy, precision, robustness, linearity, and forced degradation in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) topic Q2 (R1) ‘Validation of Analytical Procedures: Text and Methodology’. The method was linear over a concentration range of (1–7 µg/ml) with correlation coefficient of (r2 > 0.9999). The accuracy was confirmed by calculating the % recovery which was found to be 100.0–101.6%. The RSD values obtained for repeatability and intermediate precision experiments were less than 2%. The limit of detection (LOD) was 0.12 µg/ml, while the limit of quantification (LOQ) was 0.38 µg/ml. The drug samples were exposed to different stressed conditions and the results showed that all degradation products were satisfactorily separated from each other and from the peak of the drug using the developed method. The proposed method can be used for the quantitative determination of isotretinoin with confidence.

Item Type: Article
Additional Information: This is an Accepted Manuscript of an article published by Taylor & Francis in Pharmaceutical Development and Technology on 12/04/2018, available online: http://www.tandfonline.com/10.1080/10837450.2018.1454469
Uncontrolled Keywords: 1115 Pharmacology and Pharmaceutical Sciences
Subjects: R Medicine > RM Therapeutics. Pharmacology
Divisions: Pharmacy & Biomolecular Sciences
Publisher: Taylor & Francis
Related URLs:
Date Deposited: 23 Mar 2020 12:15
Last Modified: 23 Mar 2020 12:15
DOI or Identification number: 10.1080/10837450.2018.1454469
URI: http://researchonline.ljmu.ac.uk/id/eprint/10469

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