ABSTRACT
The current study was designed to evaluate mucoadhesive buccal tablet containing metronidazole [MTZ] for local action aided by Hydroxypropylmethylcellulose K4M [HPMC] and Carbopol 940® [CP] as mucoadhesive polymers with other ingredients like sodium starch glycolate [SSG], polyvinyl pyrollidone K30 [PVP] as disintegrant and binders respectively. Formulations [F1-F8] were prepared by direct compression method and characterized for different physicochemical parameters. Results showed that the average weight and friability were within USP limits. Maximum mucoadhesive time was observed for F2 [14 hr] containing moderate amount of HPMC and CP used in the study. Up most mucoadhesive strength value was observed with F3 containing highest amount of HPMC used. Results indicated that high amount of HPMC was linked with the moderate to higher mucoadhesive strength and time. Maximum swelling index was observed in F7 [191.3%]. Only F1-F3 showed complete in vitro MTZ release within 3 hr. Formulations containing PVP released MTZ incompletely over time while SSG released earlier. Formulation F1 was considered best in terms of MTZ release [100.5%] with diffusion based Korsmeyer-Peppas release kinetics. Therefore, MTZ exhibiting best physicochemical characters in mucoadhesive buccal tablet was found in F1 containing HPMC and CP in amounts of 37.5 mg and 25 mg, respectively, for local action
ABSTRACT
A Spectrophotometric method for the determination of Gemifloxacin mesylate [GFX] is developed and validated according to ICH guidelines. GFX is a fluoroquinolone that is used in the treatment of pneumonia. The analysis of the pure drug was carried out at its 'k[max] 270 nm. The method was linear from 0.5-5microg/mL, r[2] 0.999 and equation is 0.102-0.000. The % RSD for inter-day [0.969%] and intra-day [0.714%] assuring a good precision and accuracy was close to 100%. Limit of detection and Limit of quantification were 0.197 and 0.599|ug/mL, respectively
The validation results and statistical data demonstrate that the method is accurate, sensitive, cost effective and reproducible and has an importance in quality assurance of GFX analysis. The developed method was proved suitable for analysis of GFX in the pure and tablet dosage forms without interference of excepients