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Development and Validation of Stability Indicating the RP-HPLC Method for the Estimation of Related Compounds of Guaifenesin in Pharmaceutical Dosage Forms

Development and Validation of Stability Indicating the RP-HPLC Method for the Estimation of Related Compounds of Guaifenesin in Pharmaceutical Dosage Forms

Sunil Pingili Reddy, K Sudhakar Babu, Navneet Kumar, Y V V Sasi Sekhar

Pharm Methods. 2011 Oct;2(4):229-34.

PMID: 23781462

Abstract:

Aim and background:
A stability-indicating gradient reverse phase liquid chromatographic (RP-LC) method was developed for the quantitative determination of related substances of guaifenesin in pharmaceutical formulations.
Materials and methods:
The baseline separation for guaifenesin and all impurities was achieved by utilizing a Water Symmetry C18 (150 mm × 4.6 mm) 5 μm column particle size and a gradient elution method. The mobile phase A contains a mixture of 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 90:10 v/v, while the mobile phase B contains 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 10:90 v/v, respectively. The flow rate of the mobile phase was 0.8 ml/min with a column temperature of 25°C and detection wavelength at 273 nm.
Results:
Guaifenesin was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation.
Conclusion:
The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP14007091	Guaifenesin Impurity B		14007-09-1	Price

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