Quantitative and Qualitative Estimation of Marketed Naproxen Tablets Available in Bangladesh

Tanoy Saha, Md. Hassan Kawsar, Md. kamrul Islam, Safaet Alam, Mirazul Islam, Nafla Hakim, Md. Jamal Hossain
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Abstract

Naproxen is a non-steroidal anti-inflammatory drug (NSAID) working as a non-selective cyclooxygenase (COX) inhibitor to treat inflammation, pain, fever, and various disease conditions. The current study was conducted to determine and compare several in vitro quality parameters, often commercially available 500 mg naproxen brands available in Bangladesh. According to the existing protocols, different physical parameters such as uniformity of weight, hardness, friability, disintegration time and dissolution were determined. A validated UV-visible spectrophotometric approach was used to assess the content uniformity of drug material in the collected brands. All the brands taken for this study complied with the official specifications of physical parameters. These brands contained active ingredients ranging from 91.37% up to 101.18%. On the other hand, two brands (C4 and C8) of naproxen tablets failed to meet the specification of United States Pharmacopoeia (USP), 90-110% of the labeled claim for the 500 mg naproxen tablet. These sub-standard brands possessed only 88.16% and 86.67% naproxen sodium. In conclusion, the current study indicated that eight out of the ten brands complied with quality parameters and can be used correspondingly. Bangladesh Pharmaceutical Journal 25(2): 175-179, 2022 (July)
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孟加拉国市售萘普生片的定量和定性评价
萘普生是一种非甾体抗炎药(NSAID),作为非选择性环加氧酶(COX)抑制剂,用于治疗炎症、疼痛、发烧和各种疾病。目前的研究是为了确定和比较几种体外质量参数,这些参数通常是孟加拉国市售的500毫克萘普生品牌。根据现有的方案,确定了不同的物理参数,如重量均匀性、硬度、脆性、崩解时间和溶出度。采用经验证的紫外可见分光光度法对所收集品牌的药材进行含量均匀性评价。本研究采用的所有品牌均符合官方规定的物理参数。这些品牌的有效成分含量从91.37%到101.18%不等。另一方面,两个品牌(C4和C8)的萘普生片不符合美国药典(USP)的规格,占500 mg萘普生片标签声明的90-110%。这些不合格品牌的萘普生钠含量仅为88.16%和86.67%。综上所述,目前的研究表明,10个品牌中有8个符合质量参数,可以相应使用。孟加拉国医药杂志25(2):175-179,2022(7月)
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