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Amoxicillin Analytical Testing and Development Analytical test is an important test procedure used in pharmaceutical industry every two years of a drug manufacturing to test a validate characteristic of the drug substance against the specified acceptance criteria for that characteristic. The objective of this report is to outline the analytical testing procedures and development of Amoxicillin to verify drug chemistry, quality of drug and comply with FDA regulations. The choice of analytical instrumentation and methodology depend mainly on the intended purpose and scope of the analytical test procedure along with the drug parameters including linearity and limits of detection. There are several analytical testing methods that are commonly used in Amoxicillin production, for example, Coating Amoxicillin with Ethyl Cellulose, Induced Aggregation of Gold Nanoparticles using Highly Sensitive Colorimetric, Potentiometric Titration with a Platinum or Mercury Indicator and RP-HPLC Method (Preet S., Rekha R., and Sanju N., 2011). Chemically Amoxicillin is a white powder, partially soluble in cold water and hot water with chemical formula C16H19N3O5S. An isocratic high pressure liquid chromatography HPLC equipped with UV detector is the most efficient analytical test method used for analysis of pure Amoxicillin in the bulk and pharmaceutical dosage form; capsule, tablet, oral suspension and injection (Preet S. et al., 2011). First, in order to prepare stock solution of Amoxicillin, 100 mg of Amoxicillin was diluted using water and then stored below - 20oC. The solvent is later dissolved in 50 mL of potassium dihydrogen phosphate and methanol (mobile phase) and sonicated for about 20 minutes to analysis of forced degradation samples (Suresh G. and Sathish A., 2011). The solution was then diluted subsequently with the mobile phase to achieve linear concentration range of 20-100 ?g/ml (G, Suresh Babu et al., 2011). The solution was injected three time into the 20 ?L loop and the chromatogram analysis was recorded using PDA detector with a scan range of 200–400 nm (Niroush S., and Jane J., n.d.). After retention time of 6.30 minutes, the amount of Amoxicillin was calculated from a calibration curve by analyzing the peaks. For validation, 20 capsules each containing 250 mg of Amoxicillin of two different brands were taken and their average weight was calculated (Suresh G. et al., 2011). In order to validate the analytical method, the parameters such as linearity, precision, recovery, decision limit, selectivity and quantification limit (LQ) were evaluated. The evaluation of these parameters were performed by varying pH ranging from 1 to 10, solid-phase extraction and operator. To validate the stability of the drug, the solution was divided in 4 portions and stored each one at a different temperature: 2-8 ºC, 22 ºC, 37 ºC and 55 ºC, for 170 hours. Also, phosphate buffer with pH 8.2 was used which lead to good extraction recoveries. The percentage recovery was between 95% to 98% which conclude that the HPLC method is high accurate and efficient technique used for Amoxicillin analytical test and development (Suresh G. et al., 2011). References "Side Effects of Amoxil (Amoxicillin) Drug Center - RxList." RxList. Ed. Charles Patrick Davis. 2 Apr. 2015. Web. 2 Oct. 2015. <http://www.rxlist.com/amoxicillin-side-effects-drug-center.htm> PREET KAUR, SIMAR, REKHA RAO, and SANJU NANDA. "AMOXICILLIN: A BROAD SPECTRUM ANTIBIOTIC." International Journal of Pharmacy and Pharmaceutical Sciences. 7 May 2011. Web. 2 Oct. 2015. <http://www.ijppsjournal.com/Vol3Issue3/2249.pdf> G, Suresh Babu, and Sathish Kumar Shetty A. "Development and Validation of Amoxicillin by RP-HPLC Method in Bulk Drug and Pharmaceutical Dosage Forms." International Journal of ChemTech Research. Sept. 2011. Web. 2 Oct. 2015. <http://sphinxsai.com/Vol.3No.3/Chem/pdf/CT=05(1037-1041)JS11.pdf> Niroush Konari, Sarif, and Jane T. Jacobc. "Stability-indicating LC-analytical Method Development and Validation for the Simultaneous Estimation of Flucloxacillin and Amoxicillin in Pharmaceutical Dosage Form." Science Direct. Web. 9 Oct. 2015. <http://www.sciencedirect.com/science/article/pii/S1658365514000739>
