Method Development and Validation of Paracetamol, Guaifenesin, Ambroxol Hydrochloride, Phenylephrine Hydrochloride and Chlorpheniramine Maleate in Bulk and Combined Dosage Form Using RP-HPLC Technique

Swapnil B. Deshmukh*, Vilas L Badgujar, Priyanka N Chhajed, Trupti C. Mahajan, Tanvirahmad J. Shaikh
DCS’S A.R.A College of Pharmacy, Nagaon, Dhule

A B S T R A C T
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. Orthophosphoric 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 the 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 the labeled 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.