title: Stability indicating RP-HPLC method development and validation for the simultaneous determination of aminexil and minoxidil in pharmaceutical dosage form.
abstract: The objective of the present work is to develop stability indicating high-performance liquid chromatographic method for the simultaneous determination of aminexil and minoxidil in pharmaceutical dosage form. The chromatographic separation was achieved with BDS Hypersil C18 column (250 mm×4.6 mm×5 μ) as stationary phase and phosphate buffer and acetonitrile (78:22) as mobile phase. The method was employed by using a flow rate of 1.1 mL/min kept at 30°C. The detection wavelength was kept at 238 nm by using photo-diode array detector. The retention times of the aminexil and minoxidil were found to be 2.3 min and 3.9 min, respectively. The method developed was validated in accordance with ICH guidelines with respect to the stability indicating capacity of the method including system suitability, accuracy, precision, linearity, range, limit of detection, limit of quantification and robustness. The linearity responses of aminexil and minoxidil were found to be in the concentration ranges of 18.75-112.5 μg/mL and 25-150 μg/mL, respectively. The LOD and LOQ values for aminexil were found to be 0.31 and 0.92 μg/mL and minoxidil were found to be 0.03 and 0.10 μg/mL respectively. The percentage recoveries for both the drugs were found in the range of 98-101%. This method is accurate, precise and sensitive; hence, it can be employed for routine quality control of aminexil and minoxidil in pharmaceutical industries and drug testing laboratories.
authors.affiliation: Department of Pharmaceutical Chemistry, Malla-Reddy College of Pharmacy, Osmania University, 500100 Maisammaguda, Hyderabad, India.
authors.forename: S
authors.initials: S
authors.lastname: Siddiraju
authors.affiliation: Department of Pharmaceutical Analysis and Quality assurance, Malla Reddy College of Pharmacy, Osmania University, 500100 Maisammaguda, Hyderabad, India. Electronic address: sahithi1016@gmail.com.
authors.forename: M
authors.initials: M
authors.lastname: Sahithi
mesh_terms: D002851:Chromatography, High Pressure Liquid; D003497:Cyclic N-Oxides / Q000032:analysis*; D004304:Dosage Forms; D004355:Drug Stability; D057230:Limit of Detection; D008914:Minoxidil / Q000032:analysis*; D019999:Pharmaceutical Solutions; D011743:Pyrimidines / Q000032:analysis*; D015203:Reproducibility of Results
chemical_list: D003497:Cyclic N-Oxides; D004304:Dosage Forms; D019999:Pharmaceutical Solutions; D011743:Pyrimidines; C000612381:aminexil; D008914:Minoxidil
keywords: Aminexil; Aminéxil; Chromatographie liquide haute performance en phase inverse; Forme posologique pharmaceutique; Minoxidil; Pharmaceutical dosage form; Reversed phase high-performance liquid chromatography; Validation