盐酸伊伐布雷定纯剂型和制剂剂型的定量生物分析和分析方法

IF 0.7 Q4 PHARMACOLOGY & PHARMACY Journal of Reports in Pharmaceutical Sciences Pub Date : 2020-01-01 DOI:10.4103/jrptps.JRPTPS_110_19
Anjali Polker, Y. Padmavathi, Ravindra Kumar, N. Babu
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引用次数: 0

摘要

前言:建立了用紫外分光光度法和高效液相色谱法测定原料药和制剂剂型盐酸伊伐布雷定的分析和生物分析新方法。目的:建立一种新的反相高效液相色谱法测定盐酸伊伐布雷定纯度和制剂的方法,并建立一种生物样品中盐酸伊伐布雷定的生物分析方法。这些方法分别按照国际人用药品技术要求协调委员会和美国fda指南进行了验证。方法:采用反相高效液相色谱法建立替米沙坦为内标品。液液萃取后,在Waters 125A(10µ,300 × 3.9 mm) C18色谱柱上进行色谱分析,进样量为20µL,运行时间为15 min。采用乙腈和乙酸铵缓冲液pH 7.8 (60:40% vol/vol)组成的等容流动相分离药物和内标物。采用分光光度法测定了纯剂型和制剂剂型盐酸伊伐布雷定的含量。溶剂系为绝对甲醇,检测波长为287 nm。溶剂系为绝对甲醇,检测波长为287 nm。结果:该方法在2 ~ 16 μg/ mL范围内有效,准确度、精密度、选择性和鲁棒性良好。生物分析方法在500 ~ 3500 ng/mL范围内建立线性关系,回归系数r2 = 0.9994。该方法可用于大鼠血浆中盐酸伊伐布雷定的测定和市售片剂中盐酸伊伐布雷定的定量测定。结论:所建立的方法可用于盐酸伊伐布雷定制剂的定量分析,具有良好的回收率和重复性。
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Quantitative bioanalytical and analytical methods for estimation of ivabradine hydrochloride in pure and pharmaceutical dosage form
Introduction: New analytical and bioanalytical methods were developed for the estimation of Ivabradine hydrochloride in bulk and pharmaceutical dosage form by UV spectrophotometry and high-performance liquid chromatography (HPLC) technique. Objective: The primary objective of the study is to develop a new RP-HPLC method for estimation of Ivabradine Hydrochloride in pure and formulation and to develop a bioanalytical method for analysis of Ivabradine Hydrochloride in biological samples. The methods were validated as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and USFDA guidelines respectively. Methods: In Reversed-phase (RP)-HPLC method developed telmisartan is the internal standard used. After liquid–liquid extraction, the analyte and the internal standard were chromatographed on Waters 125A (10 µ, 300 × 3.9 mm) C18 column using 20-µL injection volume with a run time of 15 min. An isocratic mobile phase consisting of acetonitrile and ammonium acetate buffer pH 7.8 (60:40% vol/vol) is used to separate drug and internal standard. In Spectrophotometric bioanalytical method developed for the estimation of ivabradine hydrochloride in pure and pharmaceutical dosage form. The solvent system used is absolute methanol and detected at the wavelength of 287 nm. The solvent system used is absolute methanol and detected at the wavelength of 287 nm. Results: The Analytical method is validated according to ICH guidelines over the range of 2–16 μg/ mL, showing accuracy, precision, selectivity, and robustness. For Bioanalytical method the linearity is established in the range of 500–3500 ng/mL with the regression coefficient of r2 = 0.9994. The validated spectrophotometric method is used successfully to study ivabradine hydrochloride in rat plasma and also quantitative determination in marketed tablets. Conclusion: The proposed methods were successfully applied for the quantitation of ivabradine hydrochloride in pharmaceutical dosage form with good recovery and reproducibility.
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来源期刊
Journal of Reports in Pharmaceutical Sciences
Journal of Reports in Pharmaceutical Sciences Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
1.40
自引率
0.00%
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0
期刊介绍: The Journal of Reports in Pharmaceutical Sciences(JRPS) is a biannually peer-reviewed multi-disciplinary pharmaceutical publication to serve as a means for scientific information exchange in the international pharmaceutical forum. It accepts novel findings that contribute to advancement of scientific knowledge in pharmaceutical fields that not published or under consideration for publication anywhere else for publication in JRPS as original research article. all aspects of pharmaceutical sciences consist of medicinal chemistry, molecular modeling, drug design, pharmaceutics, biopharmacy, pharmaceutical nanotechnology, pharmacognosy, natural products, pharmaceutical biotechnology, pharmacology, toxicology and clinical pharmacy.
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