ABSTRACT

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