Fast and Accurate Quantitative Determination of Prednisolone and Chlorpheniramine in Active Pharmaceutical Ingredients and Parenteral Dosage Forms doi.org/10.26538/tjnpr/v5i11.5
Main Article Content
Abstract
The approaches for quantitative drug analysis utilizing HPLC is hectic and time-consuming. The
present research was conducted to develop an efficient and facile method for the simultaneous
quantitative analysis of chlorpheniramine (CPM) and prednisolone (Pred) with reasonable
accuracy and precision both in active pharmaceutical ingredient (API) and its parenteral dosage
forms. C18 (5µm x 150 mm 4.6 mm) HPLC column with 50:50 v/v acetonitrile: buffer (0.008M
sodium dihydrogen phosphate [NaH2PO4]) as mobile phase was used. The run time for the
analysis was 10 min, while the retention times of CPM and Pred were 1 and 4 min, respectively.
The developed method showed linearity, intermediate precision, and accuracy within the defined
set limits according to international standards. Verification of this method was done on the
parenteral dosage forms of both drugs. Linearity with R2 values of 0.991607 for CPM and
0.990061 for Pred was obtained. Limit of detection and limit of quantification for Pred were
calculated to be 0.033 and 0.11 mg/mL, while for CPM, 0.08 and 0.27 mg/mL were obtained.
Accuracy parameter outcomes for Pred were within the range of 98.16576 to 98.46571% and the
values for CPM were 98.10 to 99.57%. The validation results of the developed method are
accurate and within system suitability parameters provided by International Council for
Harmonization ICH and pharmacopeias.
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