Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF PARACETAMOL, GUAIFENESIN, AMBROXOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE IN BULK AND COMBINED DOSAGE FORM

Sravya Neeli*, Shanta Kumari Katakam

Abstract

An RP-HPLC method for the simultaneous determination of Paracetamol, Guaifenesin, Ambroxol hydrochloride, Phenylephrine hydrochloride and Chlorpheniramine maleate in tablets was developed and validated ® as per ICH and FDA guidelines. The method was carried out on a with Zodiac C18 (50mm x 4.6mm, 5μm) column. Ortho phosphoric acid buffer (1M) and Acetonitrile in the ratio (50:50v/v) used as mobile phase and flow rate of 1.5ml/min. The detection was carried out at 225nm and ambient column temperature was maintained. The linearity of the proposed method was investigated in the range 10-75μg/mL (r2= 0.999) for Phenylephrine, 200-1500 μg/mL (r2= 0.999) for Paracetamol, 20-150μg/mL (r2= 0.999) for Guaifenesin, 6-45μg/mL (r2=0.999) for Ambroxol, and 4-30μg/mL (r2=0.999) for Chlorpheniramine. The amount of both drugs estimated by the proposed method was found to be in good agreement with labelled claim. The developed method was validated for precision, accuracy, sensitivity, robustness and ruggedness. The developed method can be used for routine analysis of titled drugs in combined dosage form.

Keywords: Paracetamol, Guaifenesin, Ambroxol hydrochloride, Phenylephrine hydrochloride, Chlorpheniramine maleate, RP-HPLC, Validation, Zodiac C18 column.