DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ATROPINE SULPHATE AND DIPHENOXYLATE HYDROCHLORIDE IN BULK DRUG AND TABLET DOSAGE FORM
Sadia Tabassum*, K. Sreedevi, Maliha Masrath and Anupama Koneru
ABSTRACT
The aim of the study is to develop a stability indicating method for the concomitant determination of Atropine and Diphenoxylate in bulk and pharmaceutical dosage forms by RP-HPLC method. The method employed for the determination includes KROMASIL C18 column with the solvent system being Na2HPO4: Methanol (50:50), maintaining ambient temperature, flow rate of 1.0 ml/min and the run time was 6 minutes. Detection was carried out with a PDA detector at 225 nm and the pH was adjusted to 4.5. validation of the method was performed and the effect of Forced degradation of the sample under various conditions were evaluated. The outcomes of the method with the above selected criterion met the specifications of the regulatory guidelines such as ICH. Accuracy and recovery of the method was deduced in the range of 99-101%, linearity was perceived in the range of 50-150 μg/mLfor both Atropine and diphenoxylate. The regression coefficient values for atropine and diphenoxylate were found to be 0.997 and 1 respectively. Precision of the method was found to be less than 2 for both the drugs. Robustness of the method was evaluated and the results met the acceptance limits. Outcomes of the forced degradation studies were within the limit i.e., 5-20%, indicative of stability of drugs under various conditions. All the outcomes of the method development, validation and degradation studies proved that the method is reliable for the simultaneous estimation of above said drugs in bulk and pharmaceutical dosage forms.
Keywords: RP-HPLC, Atropine, Diphenoxylate, ICH guidelines, stability-indicating.
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