Flurbiprofen loaded gel based topical delivery system: formulation and in vitro characterization with new developed uplc method

Abstract

Objective: The purpose of this study was to formulate flurbiprofen (FLB) loaded methylcellulose (MC), hydroxypropyl methylcellulose (HPMC) and Carbopol®940 (C-940) based gel formulations with the help of dispersion method for topical application. Additionally, in this study also a new ultra performance liquid chromatography method was developed for the determination of FLB, which was not previously entered into the literature.Method: FLB loaded gel formulations with the help of dispersion method for topical application and to characterize the formulations according to physical appearance, pH, rheology, drug content, dissolution study and release kinetic study with the DDSolver software program. The UPLC method developed was validated for linearity, specificity, precision, sensitivity, accuracy, range and robustness.Results: Linearity was determined to be at a concentration range of 5-50 µg.mL -1 . The method developed for FLB was decided to be precise due to RSD values of <2%. Recovery of the method was satisfactory owing to <2%RSD value. The drug content was found to be in the range of 98.14-99.02% indicating the uniformity of the high drug content. At the 6th hour in dissolution study, the FLB release from gels prepared with MC, HPMC, C-940 reached 99.7%,99.5% and 87.60%, respectively. In the release kinetic tests with DDSolver, the release of gels prepared with MC and HPMC showed conformity with the weibull model, whereas the gel formulation prepared with C-940 showed a zero-order kinetics. Conclusion:According to the results, all gel formulations prepared have longer release times than the release of pure FLB.

Cefaclor monohydrate loaded microemulsion formulation for topical application: Characterization with new developed UPLC method and stability study

“…Range is the interval between the upper and lower concentration of active agent that have been indicated to be determined with precision, accuracy and linearity using the method as written. The accuracy and precision of the method are within the acceptable range [15]. In this study the range was observed linearly to the highest concentration (220 μg.mL -1 , R 2 :0.9999).…”

“…RSD % for retention time for six different conditions were between 0.18 and 0.64 % (Table 3), which is well inside the proposed acceptance basis of ≤5 %. RSD % for area response was from 0.15 to 0.87 %, which also passed the proposed acceptance basis of ≤2 % [15]. Therefore, it can be concluded that the method is consistent in front of the wavelength, temperature and flow rate.…”

“…Limit of quantitation (LOQ) is the lowest concentration of an analyte in a test and can be determined with acceptable precision and accuracy under the specified test conditions. Detection and quantification limits are the two principal components of method validation [15]. In this study, LOD and LOQ were calculated by linear regression and found as 0.582 µg.mL -1 and 1.765 µg.mL -1 respectively.…”

“…Method validation studies for CEF were carried out according to the literature and International Conference on Harmonization (ICH) guideline Q2(R1) [14,15,16]. Linearity of CEF for the method used was found to be 5-55 µg.mL -1 while regression equation was determined to be y=1.5931x-1.6058 by plotting concentration (x) versus normalized peak area ratio (y).…”

Evaluation of carvedilol-loaded Eudragit® nanoparticles

“…Conclusively, procedure proposed in this study can be used for routine, simultaneous and concurrent CVL determination. This stability indicating method can be adaptable for the determination of CVL in similar pharmaceutical dosage forms [3,18,19].…”