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 x 25cm, Sum, Qg column maintained at 25°C with ImLmin"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
ABSTRACT
A simple, fast, precise, economic, selectiveand accurate HPLC method for simultaneous estimation of sorbicacid, sodium picosulphate and methyl parabensodium in laxative drops has been developed and subsequently validated. Chromatographic separation was achieved using gradient elution with mix phosphate buffer pH 7.0 and acetonitrile. The column used was purospherstar C18, 5[micro]m, 25cm × 4.6mm kept at 25[degree]C with 1ml/min flow rate using detection [PDA] at 263nm. The retention times of sorbicacid, sodium picosulphate and methyl paraben sodium were found to be 4.6, 7.4 and 11.4 minutes respectively. The proposed method was found to be linear over a concentration range of 8-12[micro]g/ml for sorbic acid, 60-90[micro]g/ml for sodium picosulphate and 16-24[micro]g/ml formethyl paraben sodium respectively. The recovery was found to be 99.13-101.68% for sorbic acid, 99.81-100.21% for sodium picosulphate and 99.84-100.09% for methyl paraben sodium respectively. The limit of detection [LOD] for sorbicacid, sodium picosulphate and methyl parabensodium were found to be 0.032[micro]g/ml, 0.337[micro]g/ml and 0.131[micro]g/ml respectivelyand limit of quantitation [LOQ] for sorbicacid, sodium picosulphate and methyl parabensodium were found to be 0.097[micro]g/ml, 1.023[micro]g/ml and 0.399[micro]g/ml respectively. The method was validated with respect to specificity, precision, accuracy, linearity and robustness according to guidelines of ICH