నైరూప్య

Nonaqueous Titrimetric And Spectrophotometric Methods For The Assay Of Prochlorperazine In Pharmaceuticals

K.Basavaiah, B.C.Somashekar

Two simple, rapid and cost-effective methods based on titrimetry and spectrophotometry in non aqueous medium are described for the determination of prochlorperazine in pure form and in dosage forms. In titrimetry, the drug is dissolved in glacial acetic acid and titrated with acetous perchloric acid using, crystal violet being as indicator. Spectrophotometry involves adding different amounts of drug to a fixed amount of perchloric acid-crystal violet mixture and measuring the increase in absorbance at 570 nm. The titrimetric method is applicable over 4-20 mg range, and in spectrophotometry, Beer’s law is obeyed over range 2.5-30 μg/ml. The apparent molar absorptivity is calculated to be 7.237 × 103 l /mol /cm, with a Sandell sensitivity of 77.97 ng/cm2. The limits of detection and quantification are calculated to be 2.30 and 0.76 μg ml-1, respectively. Intra-day and inter-day precision and accuracy of the methods were evaluated as per ICH guidelines. The methods were successfully applied to the determination of PCPM in injection, the results were statistically compared with those of a reference method by applying Student’s t-test and F-test. No interference was observed from common additives found in injection solution. The accuracy and reliability of the methods were further ascertained by parallel determination by a reference method and by recovery studies via standard-addition technique.