A validated HPTLC method for the quantitative determination of duloxetine hydrochloride and 1-naphthol in bulk and pharm
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IGINAL RESEARCH PAPER
A validated HPTLC method for the quantitative determination of duloxetine hydrochloride and 1-naphthol in bulk and pharmaceutical formulation Nessreen S. Abdelhamid 1 & Ibrahim A. Naguib 1,2 & Basma H. Anwar 1
&
Maimana A. Magdy 1
Received: 21 February 2020 / Accepted: 26 July 2020 # Akadémiai Kiadó, Budapest, Hungary 2020
Abstract Duloxetine hydrochloride is an anti-depressant drug, while 1-naphthol is one of its hepatotoxic impurities. So, there was an urgent need to do simultaneous analysis for both the drug and its toxic impurity. Therefore, a validated high-performance thin-layer chromatography (HPTLC) method was established for the simultaneous separation and quantification of duloxetine hydrochloride and 1-naphthol in their binary mixture and pharmaceutical formulation. The utilized developing system consisted of a mixture of chloroform–ethyl acetate–benzene–33% ammonia solution (6:3:1:0.1, v/v). Densitometric scanning was used to detect the separated peaks at 233 nm using an ultraviolet detector. The validation of the estimated method was performed according to the International Conference on Harmonization guidelines. The results indicated that it can be used for the quality control analysis of the proposed mixture. The developed method showed advantages over the previously published TLC methods of having higher sensitivity and allowing the determination of duloxetine hydrochloride with and in the presence of its toxic impurity 1-naphthol. Keywords 1-Naphthol . Duloxetine hydrochloride . High-performance thin-layer chromatography
Abbreviations DUL Duloxetine hydrochloride HPTLC High-performance thin-layer chromatography ICH International Conference on Harmonization LOD Limit of detection LOQ Limit of quantification UV Ultraviolet %RSD Percent relative standard deviation
1 Introduction Duloxetine hydrochloride (DUL), shown in Fig. 1, is chemically identified as (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-
* Basma H. Anwar [email protected] 1
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St, Beni-Suef 62514, Egypt
2
Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, Al-Hawiah, Taif 21974, Saudi Arabia
thiophenepropylamine hydrochloride [1]. It is used to treat depression and anxiety. It helps to improve mood, to facilitate sleep, to relieve anxiety, and to enhance appetite and energy level [2]. The British Pharmacopeia [1] stated that 1-naphthol (naphthalen-1-ol), shown in Fig. 1, is a potential impurity of DUL [1]. Frequent exposure to 1-naphthol causes hepatic toxicity to humans [3]. 1-Naphthol is also toxic to fish and aquatic animals [4]. Hence, the determination of 1-naphthol concentration is important. Various methods were published for the estimation of DUL including ultraviolet (UV)–spectrophotometric methods [5, 6], thin-layer chromatography (TLC) [7], highperformance liquid chromatography (HPLC) [8–10], and ionselective electrode [11]. HPLC separation techniques [12
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