IMPURITY PROFILE AND VALIDATION OF PHARMACEUTICAL (API) BULK DRUG
نویسندگان
چکیده
منابع مشابه
RP-HPLC method development and validation for determination of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms
A new, rapid, economical and isocratic reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of eptifibatide acetate, a small synthetic antiplatelet peptide, in bulk drug substance and pharmaceutical dosage forms. The developed method was validated as per of ICH guidelines. The chromatographic separation was achieved isocratically on C18 colum...
متن کاملRP-HPLC method development and validation for determination of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms
A new, rapid, economical and isocratic reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of eptifibatide acetate, a small synthetic antiplatelet peptide, in bulk drug substance and pharmaceutical dosage forms. The developed method was validated as per of ICH guidelines. The chromatographic separation was achieved isocratically on C18 colum...
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A simple, rapid, sensitive and precise UV spectrophotometric method have been developed for the estimation of carbocisteine from bulk drug and pharmaceutical formulation. In this method carbocisteine showed maximum absorbance at about 200.4 nm in 0.1N HCl. Beer’s law was followed in the concentration range of 10 to 140 μg/ ml. Regression equation was found to be y = 0.0067 x – 0.0015 and coeffi...
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Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed, due to any side reactions. Impurity can be of three types: Impurities closely related to the product and coming from the chemical or from the biosynthetic route itself, Impurities formed due to spontaneous decomposition of the drug during the storage or on exposu...
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A simple and sensitive extractive spectrophotometric method is described for determination of tropicamide. The method is based on the reaction of tropicamide and bromocresol green. The ion-paired colored complex was extracted with chloroform at pH 3. The extracted complex showed maximum absorbance at 423 nm. The complex was stable up to 2 days and obeyed Beer's law over the concentration r...
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ژورنال
عنوان ژورنال: World Journal of Pharmaceutical Research
سال: 2017
ISSN: 2277-7105
DOI: 10.20959/wjpr201711-9604