Marketed pharmaceutical preparations containing alcohol (herbal origin and allopathic) may affect the health of\r\npatients on faulty dosing. Hence the present work aimed to estimate the alcohol contents by gas chromatographic technique and\r\nto set the method for routine quality and safety standardisation with well-founded technical support. In present work, alcohol\r\nfrom representative preparations was separated by distillation method. The method was set up for the quantitative estimation\r\nof alcohol by gas chromatography. The method was developed by changing the various parameters of gas chromatography.\r\nFurthermore the method was validated in order to confirm its reliability and potentials to use as quality control tool in QC\r\nlaboratories. In ayurvedic preparation asava, the content of alcohol (as self generated alcohol) was found between 10.00 to\r\n11.50 % v/v, while in mouthwash it was 9.90 to 10.78 % v/v, which was found to obey the label claim. The preparations were\r\nsatisfying the said quality standards as the alcohol content found by gas chromatographic analysis method was within\r\npermissible limits. The marketed preparations selected for the present investigation were found to contain the alcohol contents\r\nwithin limits as per labelled claim. The developed method satisfies all parameters for validation as per ICH guidelines.
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