The Validation and Development of Analytical Technique for the Fast and Economical Evaluation of Amoxicillin in Solid Dosage form Through UV/Visible Spectroscopy

Objective: The key objective of the study is to explore the sensitive, rapid, simple, accurate and economic UV/Vis spectrophotometric method to determine the amount of Amoxicillin trihydrate (AMTR) in bulk pharmaceuticals and in various formulations including dry powder (syrup), tablets and capsules by employing Copper sulphate buffer solution. Methodology: The current spectroscopic analysis performed with 12.5 μg/ml concentration of AMTR at 320 nm follows the Beer’s Lambert Law. The linearity range (10-15µg/ml) and regression data presented a significant correlation coefficient (r2 =0.999). The appropriate level of accuracy, precision, linearity, and mean percentage recovery of AMTR were found adequate relating to the % age error and standard deviations. Results: Amoxicillin trihydrate and its known strengths were scanned and analyzed by our validated method such as; 10.0 µg/ml Amoxicillin (80%), 11.25 µg/ml Amoxicillin (90%), 12.5 µg/ml Amoxicillin (100%), 13.75 µg/ml Amoxicillin (110%) and 15.0 µg/ml Amoxicillin (120%). Conclusions: As the recommended protocol of amoxicillin determination (spectrophotometry) is accurate, precise and statistically evaluated, therefore it could readily be employed for qualitative purposes of either for the raw material and pharmaceutical preparations.

In Vitro Development of a New Sponge-Based Delivery System for Intracanal Antimicrobial Administration in Endodontic Treatment

This study aimed to evaluate the in vitro performance of collagen-based sponges as a drug delivery system for intracanal antimicrobial administration. Four groups of loaded collagen-based sponges (A, 0.3% w/v amoxicillin trihydrate: potassium clavulanate (4:1); B, 0.03% w/v chlorhexidine gluconate [CHX]; C, 0.3% w/v amoxicillin trihydrate: potassium clavulanate (4:1) and 0.03% w/v CHX; D, 1% w/v amoxicillin trihydrate: potassium clavulanate (4:1) and 0.03% w/v CHX) were designed. Release kinetics were tested in vitro on cultures in Petri dishes, and the effect on bacterial biofilms was studied ex vivo on 114 extracted human single-rooted teeth. Biofilm formation was tested by scanning electron microscopy (SEM). Collagen sponges containing amoxicillin and chlorhexidine showed a time-sustained antimicrobial effect in vitro and were also able to destroy mature biofilms ex vivo. This datum was validated by means of SEM-based study of E. faecalis and S. aureus biofilms.

Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms

Novel, accurate, selective, and rapid high-performance liquid chromatography mass spectrometry method was developed for simultaneous analysis of amoxicillin trihydrate, dicloxacillin sodium, and their official impurity 6-aminopenicillanic acid. The chromatographic separation was carried out by applying the mixture on a C18 column (3.5 µm ps, 100 mm × 4.6 mm id) using acetonitrile:water (65 : 35 by volume) as a mobile phase within only 4 min. The quantitative analysis was executed using single quadrupole mass spectrometer in which electrospray ionization, selected ion monitoring, and negative mode were operated. The retention times were 1.61, 2.54, and 3.50 mins for amoxicillin, 6-aminopenicillanic acid, and dicloxacillin, respectively. The method was validated in linear ranges of 2–28 µg mL−1, 2–35 µg mL−1, and 1–10 µg mL−1 for amoxicillin, dicloxacillin, and 6-aminopenicillanic acid, respectively. The results obtained from the suggested HPLC/MS were statistically compared with those obtained from the reported HPLC method, where no significant difference appeared respecting accuracy and precision. According to the analytical eco-scale assessment method, the proposed method was proved to be greener than the reported one, where the analysis time and the amount of the wasted effluent decreased.

Development and Validation of a Simple HPLC-UV Method for Determination of Amoxicillin trihydrate in Bulk Drug and Pharmaceutical Dosage Forms

Background Many analytical methods for testing amoxicillin trihydrate from different monographs such as United States and British pharmacopoeia, use acetonitrile HPLC grade as an organic solvent in the mobile phase; however, this solvent is expensive and not environmentally friendly Objectives Developing and validating a simple, affordable, accurate, precise and environmentally friendly HPLC-UV method, for determining amoxicillin in formulations by using methanol HPLC grade as an organic solvent in the mobile phase Methods An HPLC system was used for developing and validation of laboratory test method which is less expensive and uses environmentally-friendly mixture of mobile phase solutions. Specificity, linearity, precision, repeatability, and accuracy were studied. Results The retention time (RT) for amoxicillin was 3.53 ± 0.020 min, and no interfering peaks were recorded with the blank, standard and sample at RT, ensuring specificity. Calibration curve of 20 to 160μg/ml was used. The correlation coefficient (r2) =0.9998, which indicates that the method has the linearity to this range of 20 to 160μg/ml. Intra- and between days' repeatability were assessed by injecting solutions three times a day and within three days. The %RSD of 0.3% and 0.7% within and between days respectively, were recorded. The %RSD was ≤ 2%, which indicates a precision of the method. An average percent recovery of 100.5±3.6% was recorded. Conclusion An environmentally-friendly, simple, affordable, selective, specific, rapid, sensitive, repeatable, with precision and accurate HPLC-UV method, has been developed and validated for the estimation of amoxicillin trihydrate in pharmaceutical dosage forms and can be adopted for the purpose of quality control. Rwanda J Med Health Sci 2021;4(1):72-83