ABSTRACT

A tricyclic antidepressant is amitriptyline hydrochloride. It is converted to nortriptyline, which prevents norepinephrine and serotonin from being reabsorbed. Amitriptyline hydrochloride only undergoes hepatic metabolism in the body. The liver demethylates amitriptyline to nortriptyline, which is the drug's main active metabolite. The proposed work's main goal is to clean and validate equipment used in the production of amitriptyline hydrochloride tablets, such as the coating pan, planetary mixer, and fluid bed drier. The developed RP-HPLC method was used to determine the residue of the selected drug. In terms of accuracy, precision, sensitivity, specificity, and robustness, the developed approach was validated. Amitriptyline hydrochloride residue was determined using the aforementioned described method during cleaning validation. The mobile phase used in this RP-HPLC chromatographic method was acetonitrile: NaH2PO4 with H3PO4 (60:40) v/v pH 2.5, with a flow rate of 1 ml/min, and the detection wavelength was 247 nm. Spinzarp C18 columns (10 cm × 4.6mm i.d. with a particle size of 5?m) were used in the development of this method. The developed method was validated according to ICH guidelines and remains unaffected by small but deliberated changes in experimental conditions. Keywords: Amitriptyline Hydrochloride; Cleaning Validation; RP-HPLC
Publication date: 01/03/2024

https://ijbpas.com/pdf/2024/March/MS_IJBPAS_2024_7845.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2024/13.3.7845