傅里叶变换红外分光光度法分析市售片剂中盐酸二甲双胍的含量

N. Nerdy, Linda Margata, Dian Ika Perbina Meliala, Bunga Mari Sembiring, Selamat Ginting, E. D. Putra, Atika Mulyati, T. K. Bakri
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引用次数: 0

摘要

2型糖尿病单药治疗的一线药物是盐酸二甲双胍,这是一种双胍类降糖药物。本研究的目的是建立、验证并应用傅里叶变换红外分光光度法鉴别和测定市售片剂剂型盐酸二甲双胍。本研究包括标准品的制备、样品的分析和方法的验证。定性分析得到的比波数分别为1645.68 cm-1和1574.8 cm-1。单基线定量分析得到的比面积范围为1701.53 cm-1 ~ 1535.66 cm-1。对所有盐酸二甲双胍市售片剂剂型进行分析,均满足定性和定量要求。方法准确度为100.22%,精密度相对标准偏差为0.48%,线性相关系数为0.9992,检出限为11.17 mg / mL,定量限为33.84 mg / mL,特异性较好。本研究成功建立了傅里叶变换红外分光光度法,并验证了该方法可用于盐酸二甲双胍市售片剂剂型的鉴别和测定。
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Application of Fourier Transform Infrared Spectrophotometry Method for Analysis of Metformin Hydrochloride in Marketed Tablet Dosage Form
The first line drug given for monotherapy for diabetes mellitus type 2 is metformin hydrochloride, which is a biguanide antihyperglycemic drug. The aim of this research was to develop, validate, and apply the Fourier Transform Infrared spectrophotometry method to identify and determine metformin hydrochloride in marketed tablet dosage form. This research included preparation of standard, analysis of samples, and validation of method. The specific wavenumber obtained for qualitative analysis was 1645.68 cm–1 and 1574.8 cm–1. The specific area obtained for quantitative analysis with a single baseline ranged from 1701.53 cm–1 to 1535.66 cm–1. All metformin hydrochloride marketed tablet dosage forms were analyzed and met all of the qualitative and quantitative requirements. The methods met the requirements of method validation for accuracy with a percentage of recovery of 100.22 %, precision with relative standard deviation of 0.48 %, linearity with a correlation coefficient of 0.9992, limit of detection of 11.17 mg per mL, limit of quantitation of 33.84 mg per mL, and good specificity results. In this study, the Fourier Transform Infrared spectrophotometry method was successfully developed and validated for application in identification and determination of metformin hydrochloride in marketed tablet dosage form.
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来源期刊
CiteScore
0.80
自引率
0.00%
发文量
15
审稿时长
24 weeks
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