Informatics Publishing Limited

Khan Hajera ¹, Mirza Shahed Baig ¹, Zahid Zaheer ¹, Khan Nazia ¹

Affiliations
1 Y.B. Chavan College of Pharmacy, Rauza Baugh, Aurangabad, IN

Abstract

A reverse phase high performance liquid chromatography (RP-HPLC) has been developed for the estimation of Gemifloxacin mesylate in bulk drug and pharmaceutical dosage form. The quantification was carried out using C18 column (250mm × 4.6mm i.d, 5 mm) in an isocratic mode with a mobile phase consisting of methanol: 7% formic acid (80:20v/v), pH was adjusted to 2.1, at a flow rate of 1 ml/min. The separation was performed at ambient temperature and detection was carried out at 260nm. The retention time of the drug was found to be 2.36min and method produced linear response in the concentration range of 10-60 μg/ml (R˜0.9991). As per ICH guidelines, the method was validated for linearity, precision, accuracy, LOD, LOQ and robustness for bulk drug and pharmaceutical dosage form.

Keywords

Gemifloxacin Mesylate, RP-HPLC Method, Validation.

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Zahid Zaheer ¹, Obaid Shaikh ¹, Sucheta Thorat ¹, Rana Z. Ahmed ¹

Affiliations
1 Y. B. Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Aurangabad-431001, IN

Abstract

A simple, accurate, cost effective and reproducible spectrophotometric method has been developed for the estimation of fluoxetine hydrochloride in bulk and pharmaceutical dosage form. UV spectrophotometric method, which is based on measurement of absorption at maximum wavelength 226 nm. The developed method was validated with respect to linearity, accuracy (recovery), precision, specificity, ruggedness and robustness. Beer’s law was obeyed in the concentration range of 5-50 μg/ml having line equation y=0.027x+0.030 with correlation coefficient of 0.999. The percentage recovery is 100.01 which reflect that the method is free from interference of the impurities and other additives during the estimation of drug in formulation. The proposed method can be successfully used for analysis of fluoxetine hydrochloride in marketed preparations. Results of the analysis were validated statistically and by recovery study.

Keywords

UV Spectrophotometry, Fluoxetine Hydrochloride.

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