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首页> 外文期刊>Der Pharma Chemica: journal for medicinal chemistry, pharmaceutical chemistry and computational chemistry >Fast and Accurate Quantitative Determination of Prednisolone and Chlorpheniramine in Active Pharmaceutical Ingredients and Parenteral Dosage Forms
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Fast and Accurate Quantitative Determination of Prednisolone and Chlorpheniramine in Active Pharmaceutical Ingredients and Parenteral Dosage Forms

机译：快速准确地定量测定活性药物成分和肠胃外剂型中的泼尼松龙和氯啡胺

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摘要

The research work entails the development of an efficient and facile method for the simultaneous quantitative analysis of Chlorpheniramine (CPM) and Prednisolone (Pred) with reasonable accuracy and precision both in active pharmaceutical ingredient (API) and its parenteral dosage form. C18 (5μm x 150 mm 4.6 mm) HPLC column was used using 50:50 v/v acetonitrile: buffer 0.008M sodium dihydrogen phosphate (NaH2PO4) as mobile phase. The run time for the analysis was 10 min. The retention times of CPM and Pred were 1 and 4 minutes. The developed method showed linearity, intermediate precision and accuracy within the defined limits set according to international standards. Verification of this method was done on parenteral dosage form of both the drugs. Linearity with R2 values of 0.991607 for CPM and 0.990061 for PRED was obtained. Limit of detection and limit of quantification for PRED were calculated 0.033 mg. mL-1 and 0.11 mg. mL-1 while for CPM, 0.08 mg. mL-1 and 0.27 mg. mL-1 were obtained. Accuracy parameters outcomes for PRED, were within range of 98.16576% to 98.46571% and the values for CPM were 98.10% to 99.57% Validation results of the developed method are accurate and within system suitability parameters provided by ICH and pharmacopeias.
机译：研究工作需要开发有效且容易的方法，用于在活性药物成分（API）和其肠胃外剂型中具有合理的精度和精度的合理精度和精度的同时定量分析的有效和容易的方法。使用50:50V / V乙腈使用C18（5μm×150mm 4.6mm）HPLC柱：缓冲液0.008M磷酸二氢钠（NaH2PO4）作为流动相。分析的运行时间为10分钟。 CPM和PRED的保留时间为1和4分钟。开发方法显示了根据国际标准的规定限制内的线性度，中间精度和准确性。该方法的验证是对药物的肠胃外剂型进行的。获得具有0.991607的R2值的线性，用于PREP的PMM和0.990061。检测极限和预热量限制计算0.033mg。 ML-1和0.11mg。 ML-1，用于CPM，0.08毫克。 ML-1和0.27毫克。得到ML-1。预测的准确性参数结果在98.16576％至98.46571％的范围内，CPM的值为98.10％至99.57％的验证结果是准确的，在ICH和Pharmacopeias提供的系统适用性参数内。

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