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Development and validation of a new spectrophotometric method for determination of tertiary aliphatic amine derivatives using venlafaxine hydrochloride as the model drug

Archana Dolly, Narendra K.Jain, Pradeep Mishra

Development or invention of a new drug(s) definitely necessitates development of analytical method for its estimation in the biological fluids, other solutions and pharmaceutical dosage forms. A new simple, rapid, precise, highly specific and economical spectrophotometric method has been developed and validated for tertiary aliphatic amine derivatives using venlafaxine hydrochloride as the model drug. The method involves formation of the picrate of the amine, extractable into chloroform, which gives a yellow color, but the absorption maximum is located in the ultraviolet range at 352.5nm. Linearitywas obtained in the concentration range 10-30g/mL (r=0.9992). Limit of detection (LOD) and limit of quantitation (LOQ) are 24.69 and 74.80g/mLrespectively.Themolar absorptivity and sandell’s sensitivity were found to be 1.088  105 and 0.003 respectively. The method was optimized and suitably validated following the guidelines for validation on analytical procedures. Validation parameters performed included linearity, accuracy, precision, sensitivity, selectivity and robustness. The method was applied to the commercial formulation of venlafaxine and the results of analysis were statistically validated to determine percent relative standard deviation (%R.S.D.), standard deviation (S.D.), standard error (S.E.) and t-values at 95%confidence level.