title: A validated stability indicating ion-pair RP-LC method for zoledronic acid.
abstract: The present paper describes the development of a stability indicating high performance liquid chromatographic (HPLC) assay method for zoledronic acid in the presence of its impurities and degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of zoledronic acid was observed under oxidative stress at higher temperature. The drug was found to be stable in other stress conditions attempted. Successful separation of the drug from the degradation products formed under stress conditions was achieved on a C18 column using a mixture of phosphate buffer that contains 7 mM tetra butyl ammonium hydrogen sulphate, an ion-pairing agent and methanol (95:5) as mobile phase. The developed HPLC method was validated with respect to response function, precision, accuracy, specificity and robustness. The developed HPLC method to determine the related substances and assay determination of zoledronic acid can be used to evaluate the quality of regular production samples. It can be also used to test the stability samples of zoledronic acid.
authors.affiliation: Analytical Research, Custom Pharmaceutical Services, Dr. Reddy's Laboratories, Hyderabad 500049, India. bmrao@drreddys.com
authors.forename: B Mallikarjuna
authors.initials: BM
authors.lastname: Rao
authors.forename: M K
authors.initials: MK
authors.lastname: Srinivasu
authors.forename: Ch Prathima
authors.initials: ChP
authors.lastname: Rani
authors.forename: S Siva
authors.initials: SS
authors.lastname: kumar
authors.forename: P Rajender
authors.initials: PR
authors.lastname: Kumar
authors.forename: K B
authors.initials: KB
authors.lastname: Chandrasekhar
authors.forename: M
authors.initials: M
authors.lastname: Veerender
mesh_terms: D050071:Bone Density Conservation Agents / Q000032:analysis / Q000737:chemistry*; D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002845:Chromatography; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004164:Diphosphonates / Q000032:analysis / Q000737:chemistry*; D004340:Drug Contamination; D004345:Drug Industry / Q000379:methods; D004355:Drug Stability; D006358:Hot Temperature; D006868:Hydrolysis; D007093:Imidazoles / Q000032:analysis / Q000737:chemistry*; D007477:Ions; D008027:Light; D008956:Models, Chemical; D010100:Oxygen / Q000032:analysis; D019999:Pharmaceutical Solutions / Q000737:chemistry; D048448:Phenylcarbamates / Q000032:analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013696:Temperature; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D007477:Ions; D019999:Pharmaceutical Solutions; D048448:Phenylcarbamates; D000077211:Zoledronic Acid; D010100:Oxygen