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Abstract
A simple, rapid, and highly selective RP-HPLC method was developed for the simultaneous determination of Azelnidipine (AZL) and Olmesartan (OLM) drug substances in the fixed dosage strength of 16 mg and 20 mg, respectively. Effective chromatographic separation was achieved using a Hypersil GOLD C18 column (150 mm × 4.6 mm internal diameter, 5 µm particle size) with a mobile phase composed of methanol, acetonitrile, and water in the ratio of 40:40:20 (by volume). The mobile phase was pumped using a gradient HPLC system at a flow rate of 0.5 mL/min, and quantification of the analytes was based on measuring their peak areas at 260 nm. The retention times for Azelnidipine and Olmesartan were about 8.56 and 3.04 min, respectively. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection, and quantification limits. Calibration curves were linear in the ranges of 2–48 μg/mL for Azelnidipine and 2.5–60 μg/mL for Olmesartan with correlation coefficients >0.990. The proposed method proved to be selective and stability-indicating by the resolution of the two analytes from the forced degradation (hydrolysis, oxidation, and photolysis) products. The validated HPLC method was successfully applied to the analysis of AZL and OLM in their combined dosage form.
Highlights
Azelnidipine (AZL), (±)-3-[1-(diphenylmethyl)azetidin-3-yl] 5-propan-2-yl 2-amino-6-methyl4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate, is a new dihydropyridine derivative with calcium antagonistic activity [1]
Very few analytical methods have been reported for the determination of AZL, which include HPLC [2, 3], an LC-MS method [4, 5], LC-ESI-MS [6, 7], and HPLC-MS-MS [8], in which two methods were for the formulation and the remaining for human plasma
We focus on the degradation study of Azelnidipine with Olmesartan
Summary
Azelnidipine (AZL), (±)-3-[1-(diphenylmethyl)azetidin-3-yl] 5-propan-2-yl 2-amino-6-methyl4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate, is a new dihydropyridine derivative with calcium antagonistic activity [1]. The recommended dosing of AZL is 16 mg per day. A literature survey revealed that AZL is not yet official in any pharmacopoeia. Very few analytical methods have been reported for the determination of AZL, which include HPLC [2, 3], an LC-MS method [4, 5], LC-ESI-MS [6, 7], and HPLC-MS-MS [8], in which two methods were for the formulation and the remaining for human plasma. No single method discussed the stability study profile. We focus on the degradation study of Azelnidipine with Olmesartan
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