Gatifloxacin

Present study aims to prepare and evaluate mucoadhesive microspheres by ionotropic gelation method. Among all the formulations M10 was selected as optimized formulation for mucoadhesive microspheres based on the evaluation parameters and drug release studies. In vitro release study of formulation M10 showed 97.11% 12 h in a controlled manner, which is essential for disease like peptic ulcer. The release order kinetics for M10 was best fit with the highest correlation coefficient was observed in Higuchi model, indicating diffusion controlled principle. The innovator Abygate conventional tablet shows the drug release of 97.23% within 1 h. FT-IR and DSC analyses confirmed the absence of drug-polymer interaction. The results obtained from evaluation and performance study of Gatifloxacin mucoadhesive microspheres that system may be useful to achieve a controlled drug release profile suitable for peroral administration and may help to reduce the dose of drug, dosing frequency and improve patient compliance when compared with marketed product.

Present study aims to prepare and evaluate mucoadhesive microspheres by ionotropic gelation method. Among all the formulations M10 was selected as optimized formulation for mucoadhesive microspheres based on the evaluation parameters and drug release studies. In vitro release study of formulation M10 showed 97.11% 12 h in a controlled manner, which is essential for disease like peptic ulcer. The release order kinetics for M10 was best fit with the highest correlation coefficient was observed in Higuchi model, indicating diffusion controlled principle. The innovator Abygate conventional tablet shows the drug release of 97.23% within 1 h. FT-IR and DSC analyses confirmed the absence of drug-polymer interaction. The results obtained from evaluation and performance study of Gatifloxacin mucoadhesive microspheres that system may be useful to achieve a controlled drug release profile suitable for peroral administration and may help to reduce the dose of drug, dosing frequency and improve patient compliance when compared with marketed product.

A simple, accurate, precise high-performance thin-layer chromatographic method for simultaneous estimation of Gatifloxacin (GAT) and Loteprednol etabonate (LOTE) in ophthalmic formulation has been developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as stationary phase. The solvent system consisted of methanol: ethylacetate: triethylamine (7:3:0.2v/v/v). Densitometric analysis was carried out at 272nm for LOTE and GAT. The system was found to give compact spots for LOTE and GAT at Rf value of0.70 and 0.29respectively. The linear regression analysis data showed a good linear relationship in the concentration range of 1-5µg/spot for LOTE and GAT. The% recovery was found to be 99-101% for GAT and 99-102% for LOTE. The correlation coefficient was found to be 0.999 for LOTE and GAT. The % RSD values indicated that the proposed method was precise. The specificity of the method was ascertained by peak purity profiling studies and the developed method was specific. The method has been successfully applied in the analysis of combined dosage form.

To develop and validate a simple, accurate & precise Spectrophotometry methods for simultaneous estimation of Gatifloxacin (Gati) and Loteprednol (Lote) in their combined pharmaceutical dosage form. Two simple, accurate, precise U.V Spectroscopy methods have been developed. First method was based on Simultaneous equation method. Here 286 nm was selected for the estimation of Gatifloxacin and 220 nm was selected for the estimation of Loteprednol. Second method was developed was second order derivative method, here Gatifloxacin was measured at 265.60nm ZCP of Loteprednol and 228.84 was selected for Loteprednol at ZCP of Gatifloxacin. Gatifloxacin and Loteprednol showed linearity in the range of 3-15μg/ml and 5- 25μg/ml in Simultaneous Equation method as well for second order derivative method. Correlation coefficient for Simultaneous estimation method is 0.9936 & 0.9968 whereas for Second order derivative it is 0.9986 & 0.9977 Both methods were validated by validation parameters and it show result where lie within its acceptance criteria as per ICH Q2 (R1) guideline. Hence, it can be successfully used for the routine analysis of Gatifloxacin and Loteprednol in their combined pharmaceutical dosage forms.

A simple, accurate, precise and sensitive RP- HPLC method has been developed for the determination of Gatifloxacin and Flurbiprofen Sodium in their pharmaceutical formulation. Chromatographic separation  was carried out on InertsilODS – 3 column (250 mm ×4.6 mm, 5µm ) as stationary phase by using mobile phase consisting of 0.02 M Phosphate buffer (pH 3.5 adjusted with orthophosphoric acid ) : Methanol (80 : 20 v/v). The flow rate was 1.5 ml/min with UV-detection at 245 nm. The retention time was found to be 2.59 min for Gatifloxacin and 5.41min for Flurbiprofen Sodium. The method was validated for various parameters according to ICH guideline. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range of 30 – 90 µg/ml and 3 – 9 µg/ml and correlation coefficient was found to be 0.9988 and 0.9992 for Gatifloxacin and Flurbiprofen Sodium respectively. The Limit of Detection for Gatifloxacin and Flurbiprofen Sodium were 1.45 and 0.028 respectively. The Limit of Quantification for Gatifloxacin and Flurbiprofen Sodium were 4.39 and 0.28 respectively.

A well developed and validated RP – HPLC method by UV- detection was used for the determination of Gatifloxacin in human plasma with metronidazole as internal standard. Solid phase extraction was involved in the process. The drug and the internal standard were eluted under isocratic mode using a 150 X 4.6 mm i.d, 5 µm Phenomenex ODS 2 C18 column. The mobile phase composed of a mixture of 5:95 % v/v methanol and 20mM mixed phosphate buffer (pH 3.5± 0.05) at a flow rate of 1.4 mL/Minute. The detection wave length of the detector was 268 nm. A volume of  50 µL was injected and the runtime of the method was 9 minutes. The method showed good linearity in the range of  50.1 to 7000.9 ng/mL. The recovery of gatifloxacin was 92.42 % with a standard deviation of 1.533 and recovery of internal standard was 87.6 %. The LOD of Gatifloxacin was 50.1 ng/mL. Matrix effects were not observed.

Dental implant is a pharmaceutical device in the form of strip with very small loading and size of 0.25 sq cm. For site-specific one-time continuous delivery of Gatifloxacin an antimicrobial compound with excellent activity against anaerobic micro-organism in the treatment of periodontal disease was prepared by solvent casting technique using ethyl cellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose K4M and Eudragit RL-100 with dibutylphthalate as plasticizer. The physicochemical parameters like thickness, weight variation, content uniformity and release characteristics were evaluated The drug release was initially high on day one to achieve immediate therapeutic level of drug in pocket, followed by marked fall in release by day two, and progressive moderate release profile to maintain therapeutic level following anomalous transport mechanism. Formulation F6 released 97.34% of drug at the end of 144 h and was considered as best formulation. In vitro antibacterial activity was carried out on Streptococcus mutans .