Objective: To develop and validate a new simple, accurate, precise and sensitive high performance liquid chromatographic method (HPLC) method for simultaneous estimation of ubidecarenone and vitamin E acetate in capsule dosage form as per international conference on harmonization (ICH) guidelines. Methods: The chromatographic separation of drugs were achieved using hypersil C8 column (250 mm x 4.6 mm, 5µ) in isocratic elution mode with a mobile phase of methanol: ethanol: n-hexane (80:10:10 v/v/v) at a flow rate of 1 ml/min with ultra-violet (UV) detection at 210 nm. Results: The optimized method produced sharp peaks with good resolution, minimum tailing factor and satisfactory retention time were found to be 5.745 min and 12.565 min for vitamin E acetate and ubidecarenone respectively. The method was linear in the range of 60-180 µg/ml for ubidecarenone and 20-60 µg/ml for vitamin E acetate with a correlation coefficient of 0.999 and 0.9993 respectively. Mean recoveries observed for ubidecarenone and vitamin E acetate were 99.85% and 99.73% respectively. The percentage relative standard deviation (% RSD) of peak area for system precision, method precision, and intermediate precision were found to be less than 0.37%. The lower degree of % RSD obtained has proved that the method was precise and robust. Conclusion: A new simple HPLC method was developed and validated as per ICH guidelines for the simultaneous estimation of ubidecarenone and vitamin E acetate and the method can be effectively applied for the routine analysis of active pharmaceutical ingredient (API) and formulations.
A rapid, simple, sensitive and accurate RP-HPLC method was developed and validated for simultaneous estimation of Levetiracetam and its preservatives (Methyl paraben and Propyl paraben) in oral liquid dosage form. The chromatographic separations were achieved on a Zorbax CN column (250×4.6 mm inner diameter, 5µm) using a mobile phase consisting of orthophosphoric acid buffer (pH 4.6)acetonitrile (75:25 v/v) at a flow rate of 1.0 mL/min with UV detection at 210nm. This system produced sharp peaks with good resolution, minimum tailing and satisfactory retention time for Levetiracetam, Methyl paraben and Propyl paraben were found to be 4.601, 9.905 and 19.291 respectively. The method was validated as per USP guidelines which include accuracy, precision, linearity and range, robustness specificity and ruggedness. The described method was linear over the range of 30-90 µg/ml for Levetiracetam with r² of 0.9999 and 60-180 µg/ml for Methyl paraben with r² 0.9997 and 20-60 µg/ml for Propyl paraben with r² 0.9999. The average recovery of the method was 98.2%, 99.3% and 98.7% for Levetiracetam, Methyl paraben and Propyl paraben respectively. The developed method is repeatable and selective for the analysis of Levetiracetam and its preservatives in oral liquid dosage form. Hence the method could be successfully applied for routine analysis. The developed method could also applicable in quality control testing in analysis of oral liquid dosage form and in process testing.
:There are many kinds of literatures were available for thiocolchicoside and lornoxicam in tablets and capsules formulation by different analytical methods such as fluorimetry, RP-HPLC, and UV, etc. Hence, this article brings a cumulative and communicative presentation of available analytical research works and was presented as a review of analytical methods for the determination of lornoxicam and thiocolchicoside in bulk and its dosage form. In this article, we summarized the available analytical methods reported so far in and around the world. The methods include UV-VIS spectrometry, HPLC, HPTLC, Stability-indicating methods with their utility for determination of thiocolchicoside and lornoxicam in biological matrices, bulk material, and different pharmaceutical formulations.
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