Stability indicating RP-HPLC method for the determination of brimonidine tartrate in active pharmaceutical ingredient in the presence of its impurities Bhadram Kalyan Chekraverthy and Krishnaveni Nagappan 1 * Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, India Background: Brimonidine Tartrate is used to reduce intraocular pressure in both short- and long-term. It can be used either alone or in in combination with other IOP lowering drugs. Numerous methods have been developed for the determination of Brimonidine Tartrate in combination or alone but there are none for estimating in conjugation with the impurities. Aim & Objective : A newer, simple, accurate and cost-effective stability indicating RP-HPLC method was developed and validated for the effective quantitative determination of Brimonidine Tartrate in active pharmaceutical ingredient, as well as in formulation in the presence of their impurities. Methods : A chromatographic separation of Brimonidine Tartrate and its impurities was achieved with a C 18 analytical column, using gradient elution with mobile phase A consisting of phosphate buffer with a pH of 4.5 and mobile phase B consisting of a mixture of acetonitrile and water (20:80, v/v). The instrumental settings included a flow rate of 1.0 mL/min, a column temperature of 40°C and a detector wavelength of 248 nm, using a uv-vis detector. Results : The drug follows linearity in the concentration range 25-125 µg/ml with correlation coefficient value 0.999. Results: The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 98-102% was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 50%, 100% and 150 %. The % recovery was found to be in the range 99.00% - 101.63%. The % R.S.D. value less than 2 indicated that the method was precise. Ruggedness of the proposed method was studied with the help of two analysts. Conclusion: The above method was a rapid and cost-effective and can be successfully applied for the routine analysis of ophthalmic dosage forms. The developed method was validated with respect to linearity, accuracy, precision, and specificity with no interferences from impurities of finished product compared to impurities that of standard. References 1. f Anal Thermoscientific.Com/Waterlibrary Water Analysis Instruments (WAI), Environmental & Process Instruments Division (EPD) cited as on 11/30/2011. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020613s031lbl.pdf cited as on 3/2016 https://www.drugbank.ca/salts/DBSALT000195 as on 16/03/2019 2. Louis B Cantor., Brimonidine in the treatment of glaucoma and ocular hypertension Ther Clin Risk Manag. 2006 Dec; 2(4): 337–346 3. Oh DJ al., Brimonidine tartrate for the treatment of glaucoma https://www.visionaware.org/info/your-eye-condition/glaucoma/ the-different-types-of-glaucoma/125 cited as on 16/03/2019SOP -Guideline for Analytical method development by HPLC.ICH Q2-(R1)-Validation of Analytical procedures.tical procedures
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