SIMPLE HPLC VALIDATED METHOD FOR THE DETERMINATION OF DILTIAZEM HYDROCHLORIDE IN HUMAN PLASMA

  • Mosab Arafat Assistant Professor (Dr) Mosab Arafat Department of Pharmaceutics , College of Pharmacy, Al Ain University of Science and Technology (64141, Abu Dhabi, Al Ain, UAE) Tel: +971501307886 Email: Mosab.arafat@aau.ac.ae

Abstract

Objectives: To develop and validate a high-performance liquid chromatographic method for determination of diltiazem hydrochloride (DLZ) in human plasma.

Methods: Mixture of n-hexane and 2-propanol (96:4, ratio) was added to plasma at sample preparation time followed by centrifuging the samples. The obtained upper organic layer was transferred and evaporated to dryness. The residue was reconstituted with a mobile phase and the supernatant was then injected onto the column. The mobile phase used was consisted of 0.2 M ammonium dihydrogen phosphate, acetonitrile, isopropyl alcohol and triethylamine (55:43:1.7:0.3, v/v) with pH adjusted to 4.5 using 85% phosphoric acid. The flow rate was 0.7 ml/min. UV detector set at 240 nm and samples were quantified using peak area.

Results: A well-resolved DLZ peak and free of interference from endogenous compounds in plasma with a retention time of 6.03 min was achieved. Recovery of DLZ was satisfactory (≥ 91.3%) over the concentration range tested 0.25 - 20 µg/ml. LOD of this assay was 0.125 µg/ml and LOQ was 0.25 µg/ml and, at this concentration, intra- and inter-day CV were 6.8 and 9.2 %, respectively. DLZ was found to be stable in plasma after storage at -80ºC, over 90 days.

Conclusion: The HPLC method described in this article was simple, sensitive, selective, reproducible, linear, precise, accurate, stability indicating and requires only a small sample volume, lending it suitable for the determination of DLZ concentration in routine measurements for pharmacokinetic/bioavailability studies.

 

Keywords: Diltiazem hydrochloride, HPLC, Assay validation, Stability indicating method.

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Author Biography

Mosab Arafat, Assistant Professor (Dr) Mosab Arafat Department of Pharmaceutics , College of Pharmacy, Al Ain University of Science and Technology (64141, Abu Dhabi, Al Ain, UAE) Tel: +971501307886 Email: Mosab.arafat@aau.ac.ae

Assistant Professor (Dr) Mosab Arafat

Department of Pharmaceutics ,

College of Pharmacy,

Al Ain University of Science and Technology

UAE

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How to Cite
Arafat, M. “SIMPLE HPLC VALIDATED METHOD FOR THE DETERMINATION OF DILTIAZEM HYDROCHLORIDE IN HUMAN PLASMA”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 6, no. 9, 1, pp. 213-6, https://innovareacademics.in/journals/index.php/ijpps/article/view/1551.
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