Development and validation of a liquid chromatographic method for the determination of the related substances of ramipril in Altace capsules

Enhanced Stability of Ramipril in Nanoemulsion Containing Cremophor-EL: A Technical Note

“…Therefore, standard buffer pH 5 was selected as an aqueous phase for the preparation of ramipril nanoemulsion. It is well known that ramipril degrades in the presence of moisture and in alkaline pH (7,8). In our experiments, when nanoemulsion formulation of ramipril was prepared using distilled water as an aqueous phase, ramipril was found to be degraded as its concentration decreased rapidly.…”

“…The degradation of ramipril is believed to occur mainly via two pathways: (a) hydrolysis to ramipril-diacid and (b) cyclization or condensation to ramipril-diketopiperazine (ramipril-DKP). These ramipril-diacid and ramipril-DKP compounds form, as indicated above, as a result of cyclization, condensation, and/or breakdown arising from exposure to heat, air, moisture, alkali addition, stress, compaction, manufacturing processes excipients, storage conditions, thermal oxidation, or other interactions or events (7)(8)(9). It is thus generally difficult to select the excipients that enable dosage forms with adequate stability.…”

“…It is also well reported in the literature that ramipril degrades in alkaline pH (7,8). Degradation of the ramipril in acidic pH is not reported; thus, formulations were prepared using different standard pH buffer solutions (I.P.…”

“…Ramipril and ramiprilat inhibit ACE and lowers blood pressure effectively (5,6). Formulation of ramipril dosage form leads to a decrease in the assay of ramipril due to mechanical stress, compression, manufacturing processes, excipients, storage conditions, heat, moisture, and alkaline pH (7)(8)(9). Since the drug is highly lipophilic (log p 3.32), it was presumed that keeping it in lipophilic environment might increase its stability.…”

Stress Degradation Studies of Ramipril by a Validated Stability-Indicating Liquid Chromatographic Method

“…There are few works related with stability studies of ramipril: stress studies for the simultaneous determination of ramipril/moexipril 4 , ramipril/ telmisartan 5 , and ramipril/hydrochlorothiazide 6 , a forced degradation study of ramipril in Altace ® capsules 7 , a stability study of ramipril at different pH 8 , a study of stability of ramipril over time in water apple juice and applesauce 9 , and a comparative study of stability over time of marketed ramipril generics tablets versus reference ramipril tablets 10 . There are other works described in the literature but for the determination of ramipril and ramiprilat in biological samples 11,12 .…”