Development and Validation of Double Divisor Ratio Spectra Derivative Method for Simultaneous Estimation of Telmisartan, Chlorthalidone and Cilnidipine in Tablet Dosage Form

D. Patel, Pinkal Patel, Janki Patel
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引用次数: 4

Abstract

: Aim: Development and Validation of Double Divisor Ratio Spectra Derivative Method for Simultaneous Estimation of Telmisartan, Chlorthalidone and Cilnidipine in Tablet Dosage Form. Method: A new method was developed for the simultaneous quantification of ternary mixtures by double divisor spectra method and validated as per International Conference on Harmonization [(ICH) Q2 (R1)] guideline. In double divisor spectra method absorption spectrum of ternary mixture divided by two of the three compounds in the mixture. Methanol used as solvent for this method. Calibration graphs were established in the range 10-50 μg/mL for Telmisartan, 7.5-17.5 μg/mL for Chlorthalidone and 5-25 μg/mL for Cilnidipine. Results: all the drugs exhibited good linearity over the reported concentration range with acceptable correlation coefficient. The method was validated according to ICH guideline parameters such as accuracy, repeatability, reproducibility showing acceptable percent relative standard deviation of less than 2. Conclusion: The proposed method demonstrated that the method is accurate, simple, precise, compounds not interference with each other and no any prior separation of compounds. © 2020 iGlobal Research and Publishing Foundation.
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双除数比光谱导数法同时测定片剂中替米沙坦、氯噻酮和西尼地平含量的建立与验证
目的:建立双除数比光谱导数法同时测定片剂剂型中替米沙坦、氯噻酮和西尼地平的含量并进行验证。方法:根据国际协调会议[(ICH) Q2 (R1)]指南,建立了双因子谱法同时定量三元混合物的新方法。在双因子光谱法中,三元混合物的吸收光谱除以混合物中三种化合物中的两种。该方法采用甲醇作为溶剂。替米沙坦10 ~ 50 μg/mL、氯噻酮7.5 ~ 17.5 μg/mL、西尼地平5 ~ 25 μg/mL范围内建立校准图。结果:所有药物在报告的浓度范围内线性良好,相关系数可接受。根据ICH指南的准确度、重复性、再现性等参数对方法进行验证,结果显示可接受的相对标准偏差小于2。结论:该方法准确、简便、精密度高,化合物间互不干扰,不存在预先分离现象。©2020全球研究与出版基金会。
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