RESI ARDIANTI. Stability Testing of Lisinopril Dihydrate in Antihypertensive
Drug. Supervised by RUDI HERYANTO and DEDI MARYADI.
Lisinopril dihydrate is an antihypertensive drug class of ACE inhibitors. Stability of Lisinopril dihydrate in the form of tablets need to be tested by the fact that drugs are not directly consumed as it produced. This tablet has been stored for 36 months with 75% room humidity. Stability test done of the physical test and chemical test. Physical tests include shape, color, hardness, dimensional and weight uniformity. The results of antihypertensive drugs still have the same physical properties with the provisions established. Chemical tests include identification and determination of active substances and decomposition of the active substances and dissolution testing. The results of determination of the active substance as Lisinopril dihydrate is 98.429%. These results meet the requirements specified in Test Specification (TS). Furthermore, decomposition of the active substances, the result of analysis showed that Lisinopril dihydrate was not decompose into Lisinopril diketopiperazin. Dissolution testing is done to determine the levels of soluble active substances in the body. This test is done for 6 tablets with an average yield 100.8% were obtained. Minimum threshold level of dissolution testing is 85%. The result of physical and chemical tests were shown that antihypertensive drug was stable until 36 months storage and still suitable for consumption.
Keyword: Antihypertensive, High Performance Liquid Chromatography (HPLC), Lisinopril dihydrate, Stability