The http://www.selleckchem.com/products/Bosutinib.html authors are also thankful to the management and principal of MGV’s Pharmacy College, Nashik, for providing necessary facilities. Footnotes Source of Support: Nil Conflict of Interest: None declared.
Guaifenesin, (+)-3-(2-methoxyphenoxy)-propane-1,2-diol, is a widely used expectorant, useful for the symptomatic relife of respiratory conditions [Figure 1]. Its empirical formula is C10H14O4, which corresponds to a molecular weight of 198.21. It is a white or slightly gray crystalline substance with a slightly bitter aromatic taste. Its solid oral dosage form is available as extended release tables for oral administration.[1] Figure 1 Structures of guaifenesin and its impurities In the literature survey, there were several LC assay methods have been reported for determination of guaifenesin in pharmaceutical preparation[2�C9] and in human plasma by LC-MS.

[10�C12] So far to our present knowledge, no stability indicating the HPLC method has been reported for the estimation of guaifenesin impurities and degradation products present in pharmaceutical formulation. Hence, we have developed a simple reproducible gradient stability indicating the reverse phase liquid chromatographic (RP-LC) method for the quantitative determination of degradation products and ��-isomer and guaiacol impurities [Figure 1] present in guaifenesin pharmaceutical dosage forms. The developed LC method was validated with respect to specificity, limit of detection and quantification, linearity, precision, accuracy, and robustness. Force degradation studies were performed on the placebo and drug products to show the stability-indicating nature of the method.

These studies were performed in accordance with established ICH guidelines.[13�C15] MATERIALS AND METHODS Chemicals and reagents The samples of guaifenesin-extended release tablets and its impurities were supplied by Dr. Reddy’s laboratories limited, Hyderabad, India. The HPLC grade methanol and analytical grade KH2PO4 and ortho-phosphoric acid were purchased from Merck, Mumbai, India. High purity water was prepared by using Millipore Milli-Q Plus water purification system (Millipore, Milford, MA, USA). Equipments The chromatography analysis was performed using Waters Alliance 2695 separation module (Waters Corporation, Milford, USA) equipped with 2489 UV/visible detector or 2998 PDA detector (for specificity and forced degradation studies), degasser, quaternary pump, and auto sampler system.

The output signals were monitored Anacetrapib and processed using Empower 2 software. Cintex digital water bath was used for hydrolysis studies. Photo-stability studies were carried out in the photo-stability chamber (Sanyo, Leicestershire, UK). Thermal stability studies were performed in a dry air oven (Cintex, Mumbai, India). The pH of the solutions was measured by a pH meter (Mettler-Toledo, Switzerland).