Validated Stability-Indicating Thin Layer Chromatographic Determination of Nadifloxacin in Microemulsion and Bulk Drug Formulations

• Published in: Yàowu shi͡p︡in fenxi Vol. 18; no. 5; pp. 358 - 365
• Main Authors: KUMAR, ANIL, SINHA, SHILPI, AGARWAL, S P, ALI, JAVED, AND, ALKA AHUJA
• Format: Journal Article
• Language: English
• Published: 台灣 衛生福利部食品藥物管理署 01.10.2010; Food and Drug Administration
• Subjects: fluoroquinolone; high performance thin layer chromatography; MEDLINE; method validation; nadifloxacin; SCIE; Scopus; stability-indicating assay method; method validation; high performance thin layer chromatography; fluoroquinolone; nadifloxacin; stability-indicating assay method
• ISSN: 1021-9498; 2224-6614

A stability-indicating high performance thin layer chromatographic (HPTLC) method for the densitometric analysis of nadifloxacin in microemulsions was developed and validated according to the guidelines of the International Conference on Harmonization (ICH). The compact spot for nadifloxacin was found at an Rf value of 0.39 ± 0.02 at an absorption wavelength of 288 nm using a mobile phase consisting of chloroform : methanol : formic acid (7.5 : 2.0 : 0.5 v/v). The linear regression data for the calibration plots (r2 = 0.9981) was found with respect to peak area in the concentration range of 50 - 600 ng/spot. The limit of detection (LOD) and limit of quantification (LOQ) were 9.4 and 20.5 ng respectively. The drug was subjected to acid and alkaline hydrolysis, oxidation, photo degradation and dry heat treatment. The peaks of degradation products were well-resolved from the peak of the standard drug with significantly different Rf values. Statistical analysis revealed that the developed HPTLC method is reproducible, selective and accurate for the determination of nadifloxacin in its formulations. The method can effectively separate the drug from its degradation products and be used for stability-indicating assay.