For in vivo pharmacokinetic studies, it is pre-requisite to quantify drug concentrations in plasma. In the present study a RP-HPLC procedure was developed and validated for the assessment of ketoprofen in human plasma...For in vivo pharmacokinetic studies, it is pre-requisite to quantify drug concentrations in plasma. In the present study a RP-HPLC procedure was developed and validated for the assessment of ketoprofen in human plasma. For this purpose mobile phase consisting of methaol:water (70:30) adjusted to pH 3.3 with phosphoric acid was used, and chromatography was carried out on Discovery HS C18 column, 5 μm (25 cm × 4.6 mm). The flow rate was 1 mL·min-1 and quantitative assessment was performed at 260 nm. The retention time was found to be was found to be accurate and illustrated linearity from 0.2441 to 125 μg·mL-1 with the determination coefficient (r2) of 0.9999, also accuracy and precision were found to be <2 (%RSD). The intraday accuracy for concentrations 62.5 μg·mL-1, 15.625 μg·mL-1, 7.812 μg·mL-1 and 1.953 μg·mL-1 were found to be 99.747%, 99.475%, 98.457% and 99.824% respectively where as for interday accuracy consecutive values for days 1, 2 and 3 were 99.104%, 99.091%, 98.96% and 99.385% in plasma. All validation parameters were assessed and were found to be within the limits. The proposed method was accurate, specific, quick (retention time < 10 min), selective (showed no interference with excipients), cost effective and a good resolution which gave this method an advantage over the different other reported methods for the estimation of ketoprofen in human plasma.展开更多
In the present study, we aimed to determine the quality of different brands(Test1–Test6) of mefenamic acid, which are commercially available in local market of Karachi, Pakistan. Various quality evaluation tests, inc...In the present study, we aimed to determine the quality of different brands(Test1–Test6) of mefenamic acid, which are commercially available in local market of Karachi, Pakistan. Various quality evaluation tests, including weight variation, hardness, thickness, friability, disintegration, assay and drug release, were carried out. Results were found to be in acceptable limits. Moreover, release profiles were compared using different dissolution media, such as phosphate buffer pH 6.8, 7.4 and biorelevant media(FaSSGF, FaSSIF, FeSSIF and SCoF). Release profiles at pH 6.8 and 7.4 were evaluated by one--way ANOVA, model-independent and model--dependent methods. Results of ANOVA showed that no significant difference was found among tester and reference brands(Test1–Test6). Similarly, all the brands were found to be best fitted with Weibull model.展开更多
文摘For in vivo pharmacokinetic studies, it is pre-requisite to quantify drug concentrations in plasma. In the present study a RP-HPLC procedure was developed and validated for the assessment of ketoprofen in human plasma. For this purpose mobile phase consisting of methaol:water (70:30) adjusted to pH 3.3 with phosphoric acid was used, and chromatography was carried out on Discovery HS C18 column, 5 μm (25 cm × 4.6 mm). The flow rate was 1 mL·min-1 and quantitative assessment was performed at 260 nm. The retention time was found to be was found to be accurate and illustrated linearity from 0.2441 to 125 μg·mL-1 with the determination coefficient (r2) of 0.9999, also accuracy and precision were found to be <2 (%RSD). The intraday accuracy for concentrations 62.5 μg·mL-1, 15.625 μg·mL-1, 7.812 μg·mL-1 and 1.953 μg·mL-1 were found to be 99.747%, 99.475%, 98.457% and 99.824% respectively where as for interday accuracy consecutive values for days 1, 2 and 3 were 99.104%, 99.091%, 98.96% and 99.385% in plasma. All validation parameters were assessed and were found to be within the limits. The proposed method was accurate, specific, quick (retention time < 10 min), selective (showed no interference with excipients), cost effective and a good resolution which gave this method an advantage over the different other reported methods for the estimation of ketoprofen in human plasma.
文摘In the present study, we aimed to determine the quality of different brands(Test1–Test6) of mefenamic acid, which are commercially available in local market of Karachi, Pakistan. Various quality evaluation tests, including weight variation, hardness, thickness, friability, disintegration, assay and drug release, were carried out. Results were found to be in acceptable limits. Moreover, release profiles were compared using different dissolution media, such as phosphate buffer pH 6.8, 7.4 and biorelevant media(FaSSGF, FaSSIF, FeSSIF and SCoF). Release profiles at pH 6.8 and 7.4 were evaluated by one--way ANOVA, model-independent and model--dependent methods. Results of ANOVA showed that no significant difference was found among tester and reference brands(Test1–Test6). Similarly, all the brands were found to be best fitted with Weibull model.
