Exploring the Use of Sodium Benzoate as Hydrotrope for the Estimation of Lornoxicam in their Marketed Formulation

T. Shukla, P. Khare, N. Thakur, V. Dhote, H. S. Chandel, S. Pandey
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引用次数: 1

Abstract

Increasing the aqueous solubility of insoluble drugs is of major importance for the estimation by spectrophotometric technique. Various techniques have been employed to enhance the aqueous solubility of poorly water soluble drugs. Hydrotropic solubilization is one of them. In the present study, sodium benzoate was chosen as hydrotrope to enhance the solubility of Lornoxicam for its spectrophotometric estimation in their marketed formulation. Preliminary solubility of Lornoxicam, spectral study, method development and its validation was done as per ICH guidelines. Solubility study of Lornoxicam displayed a signifi cant increment in the solubility due to 10% solution of sodium benzoate which will be suffi cient to extract the drug from its dosage form. The sample solution has shown the λ max at 376 nm and obeys the lambert beer law in the concentration range of 5-25 μg/ml with a correlation coeffi cient of 0.999. The accuracy of the method was proved by recovery study with mean recovery of 99.87. Precision study also shows no signifi cant deviation from the mean value. A limit of detection and limit of quantitation result indicates the sensitivity of the method with the values 1.02 μg/ml and 3.39 μg/ml simultaneously. Hence, the methodology can be used safely and effectively for the routine estimation of Lornoxicam in the bulk drug and marketed formulation. Key words: Hydrotropic solubilization, sodium benzoate, spectrophotometric estimation, validation.
探索使用苯甲酸钠作为水变性物对氯诺昔康市售制剂进行评估
提高不溶性药物的溶解度对分光光度法测定具有重要意义。各种技术已被用于提高水溶性差的药物的水溶性。亲水增溶就是其中之一。在本研究中,选择苯甲酸钠作为疏水剂,以提高氯诺昔康的溶解度,用于其上市配方的分光光度测定。氯诺昔康的初步溶解度、光谱研究、方法开发和验证均按照ICH指南进行。氯诺昔康的溶解度研究表明,10%的苯甲酸钠溶液足以将药物从其剂型中提取出来,从而使氯诺昔康的溶解度显著增加。样品溶液在376 nm处出现λ max,在5 ~ 25 μg/ml浓度范围内符合朗伯啤酒定律,相关系数为0.999。加样回收率为99.87,证明了该方法的准确性。精度研究也表明与平均值没有显著偏差。检测限和定量限表明,该方法灵敏度分别为1.02 μg/ml和3.39 μg/ml。因此,该方法可安全有效地用于原料药和上市制剂中氯诺昔康的常规估计。关键词:亲水增溶;苯甲酸钠;分光光度法;
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