UHPLC-UV Method for Simultaneous Determination of Perindopril Arginine and Indapamide Hemihydrate in Combined Dosage Form: A Stability-Indicating Assay Method

Abstract

Perindopril arginine and Indapamide hemihydrate in combination were proven to have a synergistic antihypertensive impact when compared with the use of each component alone. Therefore, a new Ultra-High Performance Liquid Chromatography coupled with Ultraviolet detector (UHPLC-UV) method has been developed and subsequently validated for simultaneous determination of the anti-hypertensive combination of Perindopril arginine and Indapamide hemihydrate. The separation of Perindopril arginine and Indapamide hemihydrate was achieved using a BEH C18 (1.7 μm, 2.1 × 50 mm) analytical column (Waters® Acquity UPLC) and a mobile phase composed of 0.01% v/v formic acid in water adjusted to pH 4 with acetic acid and acetonitrile (40:60 v/v). The method was able to separate Perindopril arginine and Indapamide hemihydrate within less than 4.5 min with high accuracy, precision, resolution, and sensitivity. The content of Perindopril arginine and Indapamide hemihydrate present in the dosage form Coversyl Plus® (5000 µg of Perindopril arginine/1250 µg of Indapamide hemihydrate) was determined in triplicate to give a concentration of 4991 µg and 1247 µg, respectively, from the manufacturer’s stated amounts with Relative Standard Deviation (%RSD) of ±0.63% for Perindopril arginine and ±0.84% for Indapamide hemihydrate. Moreover, the degradation products of the combination were elucidated by UHPLC-Quadrupole Time of Flight-Mass spectrometry (UHPLC-QToF-MS) under acidic, basic, and thermal conditions. In conclusion, the developed UHPLC-UV method was sensitive, rapid, and precise. Furthermore, forced degradation studies were performed and the degradants were identified by UHPLC-Electro-Spray Ionization-QToF (UHPLC-ESI-QToF).

Development of a Robust UPLC Method for Simultaneous Determination of a Novel Combination of Sofosbuvir and Daclatasvir in Human Plasma: Clinical Application to Therapeutic Drug Monitoring

“…The stability of SF and DC in human plasma samples at five levels (LLOQ, LQ, MQ, HQ, and ULOQ) was investigated under the following conditions that the common and routine clinical samples are usually subjected to [ 29 – 31 ]: (a) after three freeze-thaw cycles (24 hours at −80°C to room temperature) on plasma samples spiked with SF and DC, the recovered concentrations of SF and DC were very similar to those of freshly spiked plasma samples. In addition, no decomposition products of SF or DC were detected during (b) short-term storage (48 h) of plasma samples at RT and (c) long-term storage at −80°C for 6 months as illustrated in Table 3 which confirms the high stability of both SF and DC in human plasma samples both at RT and at −80°C.…”

Concepts for a New Rapid and Simple HPLC Method for Simultaneous Determination of Rosuvastatin and Perindopril in Dosage Forms

“…Other metabolites do not demonstrate activity in the inhibition of ACE under experimental conditions [28]. The analytical methods for the determination of perindopril in its pure or dosage forms comprise spectrophotometry [29][30][31][32][33][34][35][36][37][38][39][40][41][42], spectrofluorimetry [43][44][45], HPLC [40][41][42][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60], and so on. Anwar S. et al published an article in 2020 about the development and in vitro characterization of rosuvastatin, perindopril, and ezetimibe-loaded instant release buccal films from the pharmaceutical technology aspect [60]; however, this method has some drawbacks: It has not achieved and presented resolution between the first two peaks approaching the void volume of the column, and the bad-shaped "finger-type" peak apex of the last eluting rosuvastatin is due to the approaching solubility limit in the phosphate salt buffered mobile phase, thus reducing accuracy, sensitivity and simplicity, and rapidity of the method.…”

“…Other metabolites do not demonstrate activity in the inhibition of ACE under experimental conditions [28]. The analytical methods for the determination of perindopril in its pure or dosage forms comprise spectrophotometry [29–42], spectrofluorimetry [43–45], HPLC [40–42, 46–60], and so on. Anwar S. et al.…”

Isolation of Branched Chain Aminoacids (Valine, Leucine and Arginine) Using Maghemite Particles

“…Nowadays, various methods are developed for branched chain amino acids (BCAAs) such as valine, leucine and arginine determination. Most of them are based on chromatography (GC, LC, UHPLC) [8] with tandem of mass spectrometry (MS) [9], IEC [10] or CE [11]. In our paper, we decided to use ion exchange chromatography with post-column ninhydrin derivatization and VIS detector for valine, leucine and arginine detection [10].…”