Development and validation of a RP-HPLC method for estimation of prulifloxacin in tablet dosage form

Abstract

A simple, precise, rapid, accurate and economic reverse phase high performance liquid chromatographic method has been developed for the estimation of prulifloxacin in tablet dosage form. The separation was achieved by using octadecylsilane column (C18) and KH2PO4 buffer: acetonitrile adjusted to pH 7.3 with triethyl amine in proportion of 10:90 v/v as mobile phase, at a flow rate of 1.0 ml/min. The detection was carried out at 278 nm. The retention time of prulifloxacin was found to be 2.4 min. The limit of detection and limit of quantitation were found to be 0.14 μg/ml and 0.42 μg/ml respectively. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity, precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of prulifloxacin in tablet dosage form.

Analytical Methods for Determining Third and Fourth Generation Fluoroquinolones: A Review

“…PRULI is rapidly metabolized by paraoxogenases to ULI. It is applied in simple cystitis treatment, acute exacerbation of chronic bronchitis, and lower urinary tract infections in children and adults [ 70 , 71 ]. GEMI is a broad bactericidal spectrum drug.…”

“…ULI was also considered as an impurity of PRULI [ 88 ]. Both compounds were analysed by HPLC techniques with UV [ 70 , 88 , 89 ] or MS detection [ 71 , 90 ] and CE [ 91 ]. The following MRM transitions were observed for PRULI in MS/MS analysis: m / z 462 → 444; m / z 462 → 418; m / z 460 → 360; m / z 462 → 350 [ 90 ].…”

“…For ULI the following MRM in MS/MS detection was employed m / z 350 → 248 [ 71 ]. The analysed matrices were tablets [ 70 , 88 ], degradation products [ 90 ], aqueous human humor [ 89 ], plasma [ 71 ], and urine [ 91 ]. The separation was performed on C18, C8, and HILIC columns.…”

“…The separation was performed on C18, C8, and HILIC columns. The mobile phase consisted of ACN [ 70 , 88 – 90 ] and methanol [ 71 ] as an organic content. ACN can be replaced with alcohol; however, in this case its content must be higher to achieve the same degree of retention on HILIC column [ 88 ].…”

“…ACN can be replaced with alcohol; however, in this case its content must be higher to achieve the same degree of retention on HILIC column [ 88 ]. The other contents of mobile phase were dihydrogen potassium phosphate [ 70 ], ammonium acetate [ 88 ], phosphoric acid [ 89 ], formic acid in MS detection [ 71 , 90 ]. The BGE in CE consisted of sodium citrate, citric acid, and sodium sulfite [ 91 ].…”