ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR LIMIT OF N-NITROSODIMETHYLAMINE BY LC-MS/MS OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL EXTENDED-RELEASE TABLETS

As a result of the devotion of The Limit of N-Nitrosodimethylamine (NDMA), a rapid and selective LC/MS/MS technique was created and validated for Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-Release Tablets. The ionization mode of Atmospheric pressure chemical ionization (APCI) was used with high-performance liquid chromatography-tandem mass spectrophotometry (LC-MS/MS). Separation of N-Nitrosodimethylamine (NDMA) was performed on Inertsil ODS-4 (250 mm X 4.6 mm), 5μm column with a run time of 40 minutes. A mixture of Methanol and Buffer solution (630 mg of ammonium format into 1000 mL of purified water) in the ratio of (10:90, v/v) was used as the mobile phase A. A mixture of acetonitrile and methanol comprised the mobile phase B in the ratio of (50:50) % v/v. Analytes were extracted from Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-Release Tablets. According to the International council for Harmonization of technical requirement for Pharmaceuticals for Human Uses (ICH) standards, the accuracy, precision, selectivity, recovery, and stability of the method have been validated. Over a concentration range of 0.4 -3.6 ng/mL, the technique exhibited linearity. for N- Nitrosodimethylamine of Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-Release Tablets with an acceptable correlation coefficient applies (1/X2) linear regression with weights A pharmaceutical study can benefit from this method because it is simple, fast, precise, and accurate, making it ideal for pharmaceutical research.