title: Chromatographic resolution of drug analogues: 3-hydroxy-3-methylglutarylcoenzyme A reductase inhibitors (statins).
abstract: A high performance liquid chromatographic method for the simultaneous determination both qualitative and quantitative of cholesterol lowering statin drugs in pharmaceutical formulations has been developed. The most important advantage of developed method is that all seven statin drugs can be determined on a single chromatographic system without modification in detection wavelength. An organic modifier addition (25% v/v methanol) in the presence of buffer (20mM ammonium acetate; pH 4.0 adjusted with dilute acetic acid) played a key role in the resolution of statin drugs in gradient elution with acetonitrile. The drugs were separated on a Purospher Star 4.6mm × 25cm, 5μm, C18 column maintained at 25°C with 1mLmin(-1) flow rate using ultra violet detection at 240nm. Good separation (Rs > 2.5) was achieved in a short analysis allowing simultaneous determination of all seven statins. The effect of variation in flow rate, detection wavelength and column oven temperature was also studied. The proposed method was statistically validated in terms of precision, accuracy, linearity, specificity and robustness. The newly developed method proved to be specific, robust and accurate for the quantification of seven statins in commercial pharmaceutical formulations.
authors.affiliation: Department of Chemistry, Government College University, Lahore, Pakistan.
authors.forename: Muhammad Saqlain
authors.initials: MS
authors.lastname: Tahir
authors.affiliation: Department of Chemistry, Government College University, Lahore, Pakistan.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Adnan
authors.affiliation: Biotechnology and Food Research Centre, PCSIR, Lahore, Pakistan.
authors.forename: Quratulain
authors.initials: Q
authors.lastname: Syed
mesh_terms: D002021:Buffers; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards; D006863:Hydrogen-Ion Concentration; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000302:isolation & purification*; D057230:Limit of Detection; D016014:Linear Models; D012015:Reference Standards; D015203:Reproducibility of Results; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet
chemical_list: D002021:Buffers; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D012997:Solvents