DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH

Abstract

Objective: To develop a simple, rapid, accurate, robust and inexpensive spectrophotometric method for the estimation of benidipine hydrochloride by using quality by design (QbD)” approach.Methods: A UV spectrophotometric method was developed on Shimadzu UV-1800 double beam spectrophotometer using methanol as solvent and wavelength of 236 nm was selected as absorbance maxima (𝜆max). Effect of input variables on spectrum characteristics were studied for the selection of critical parameters and proposed method was validated for various parameters like system suitability, linearity, precision, accuracy, detection limits and quantification limits as per the International Conference on Harmonization guidelines ICH Q2(R1).Results: Linearity of the method was found to be excellent over the concentration range 3 to 18 µg/ml with high correlation coefficient value of 0.9999. Limits of detection and quantification were found to be 0.20 µg/ml and 0.60 µg/ml respectively. The mean recovery was found to be 100.35 % with low percentage relative standard deviation (% RSD) value. The precision study also has shown low % RSD value (<1). No interfering peaks were observed during specificity studies.Conclusion: Obtained result indicated that the developed spectrophotometric method is robust and efficient for the determination of benidipine hydrochloride.

Approach of the State Pharmacopeia of Ukraine to Analytical Procedures Validation on the Example of Chloride Ions Assay in Peritoneal Dialysis Solutions

“…Among such variations can be the stability of analytical solutions, different equipment, different analysts, etc. (17)(18)(19). For its essence, robustness is connected with intermediate precision (inter-assay precision) (15,(17)(18)(19).…”

“…(17)(18)(19). For its essence, robustness is connected with intermediate precision (inter-assay precision) (15,(17)(18)(19). For the robustness study of the analytical procedure, the two model solutions with the nominal content of chlorides of 100 % (model solution 5 and solution III) were compared.…”

“…ICH Topic Q2 (R1) and the SPU do not provide maximally permitted RSD for repeatability studies using three or six replicates (17,18). However, some researchers put 2% as maximum RSD of assay results of six replicates for intra-assay precision evaluation (16,19,20). The RSD of the repeatability studies was 0.22%.…”

Development and validation of stability indicating UPLC method for the estimation of ticagrelor in bulk and its tablet dosage form

“…System precision was determined on six replicate injections of standard preparations. Number of theoretical plates and asymmetry were measured [9][10] The system suitability parameters were determined by preparing standard solutions of Ticagrelor (60ppm) and the solutions were injected six times and the parameters like peak tailing, resolution and USP plate count were determined. The % RSD for the area of six standard injections results should not be more than 2%.…”

Formulation and Evaluation of Amoxicillin-Trihydrate, Metronidazole and Famotidine Loaded-Mucoadhesive Gastro-Retentive Films

“…Quantitation of in vitro antimicrobial activity of formulations was done in term of % growth inhibition. The method selected for proposed study was turbidometric based on optical density measurements [11,12]. 10 ml suspension of H. pylori in brucella broth (10 9 CFU/ml) was taken in culture flasks; weights of Different group of formulations were calculated according to MIC of all three drugs (amoxicillin, metronidazole and famotidine) and added to it and the flasks were incubated in microaerophilic environment at 37 °C.…”