RP-HPLC method for simultaneous estimation of propranolol hydrochloride and flunarizine dihydrochloride in their combined dosage formulation

B. Patel, A. K. Doshi, C. Patel
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引用次数: 5

Abstract

Aim: A simple, precise and accurate RP-HPLC method with UV-Visible detector has been developed and subsequently validated for the simultaneous determination of propranolol hydrochloride (PRP) and flunarizine dihydrochloride (FLU) in their combined dosage formulation. Materials and Methods: The separation was based on the use of a Kromasil C8 analytical column (150 × 4.6 mm, i.d., 5 μm). The mobile phase consisted of a mixture of 70 volumes of methanol and 30 volumes of 10 mM phosphate buffer (pH 3.8). The separation was carried out at 40°C temperature with a flow rate of 0.8 ml/ min. Result and Conclusion: Quantitation was achieved with UV detection at 242 nm, with linear calibration curves at concentration ranges of 32-72 μg/ml for PRP and 8-18 μg/ml for FLU. The recoveries obtained were 98.97-101.10% and 98.86-102.27% for PRP and FLU, respectively. The method was validated according to the ICH guidelines in terms of linearity, accuracy, precision, specificity, robustness, limits of detection, limit of quantitation, and system suitability of analytical method validation.
盐酸心得洛尔与盐酸氟桂利嗪联合剂型中含量的反相高效液相色谱法测定
目的:建立一种简便、精确、准确的紫外可见检测器反相高效液相色谱法,用于同时测定盐酸心得洛尔(PRP)和盐酸氟桂利嗪(FLU)联合剂型中的含量。材料和方法:采用Kromasil C8色谱柱(150 × 4.6 mm, id, 5 μm)进行分离。流动相由70体积甲醇和30体积10 mM磷酸盐缓冲液(pH 3.8)的混合物组成。结果与结论:采用242 nm紫外检测,在浓度范围为32 ~ 72 μg/ml和8 ~ 18 μg/ml的范围内建立了线性校准曲线。PRP和FLU的加样回收率分别为98.97 ~ 101.10%和98.86 ~ 102.27%。根据ICH指南对该方法进行了线性、准确度、精密度、特异性、鲁棒性、检出限、定量限和分析方法验证的系统适用性等方面的验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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