ESTIMATION OF DIMENHYDRINATE IN BULK AND PHARMACEUTICAL DOSAGE FORM: METHOD DEVELOPMENT AND VALIDATION
Yuvraj G. Jadhav, Upendra C. Galgatte*, Pravin D. Chaudhari
*Department of Pharmaceutics, P. E. Society’s Modern College of Pharmacy, Sector 21, Yamunanagar, Nigdi, Pune – 411 044, Maharashtra, India
A simple, accurate and precise spectroscopic method has been developed and validated for quantitative estimation of dimenhydrinate in bulk and pharmaceutical tablet dosage form. Dimenhydrinate was found to be soluble in phosphate buffer pH 6.8; hence, all validation parameters were carried out in phosphate buffer pH 6.8 as a solvent. Dimenhydrinate was dissolved in phosphate buffer pH 6.8 and then solution was scanned in the range of 200 – 400 nm in a 1cm quartz cell in a double beam Shimadzu UV spectrophotometer. The λmax of drug was found to be 278 nm. The method obeys Beer’s law in the range of 2-20 µg/ml concentrations. The correlation coefficient (R2) was found to be 0.999. The LOD and LOQ were found to be 0.75 and 2.272μg/ ml respectively. The accuracy of method was carried out by recovery studies. The method was validated as per ICH guidelines. The method showed good reproducibility and recovery with % relative standard deviation (RSD) less than 2. The developed method was found to be simple, precise, accurate for the estimation of dimenhydrinate in bulk and pharmaceutical dosage forms. Hence, it can be carried out in routine analysis for validation of dimenhydrinate in bulk and marketed formulation.