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Author, year (references) | Study area | Method of chemical stability test | Source drug for extemporaneous formulation | Storage conditions of extemporaneous formulation | Stability result of oral extemporaneous liquid formulation |
Chemical stability result | Physical stability result | Microbiological stability study |
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Alemón-Medina et al., 2015 [5] | Mexico | UPLC-UV | Metformin tablet | 25 ± 2°C by exposing to light and dark, 4°C in the dark, and 40°C in the dark for 30 days | Stable at all storage conditions (>90% of the initial amount) (i) No change in pH | Stable (no change in color, no foreign particles, and no turbidity) | — |
Alemon-Medina et al., 2012 [6] | Mexico | UPLC-UV | Glucophage® tablets (metformin) | 25 ± 2°C by exposing to light and dark, 4°C in the dark, and 40°C in the dark for 30 days | Stable (>90% of its initial content) | Physically stable for 30 days | Stable (no apparent bacterial or yeast growth) |
Ali et al., 2016 [11] | The United Arab Emirates | UV-spectrophotometer | Furosemide tablet | 4 and 25°C for 90 days | Stable (>98%) | Stable (no change in viscosity, color, odour, and dispersibility) | Stable (no apparent bacterial) |
Boscolo et al., 2020 [12] | Argentina | HPLC | Omeprazole pellets | Stored in 4°C and 25°C temperature for 150 days | (i) At 4°C, stable for at least 150 days (ii) Stable for 14 days at 25°C (iii) No change in pH | (i) Physically stable (no change in color, redispersibility, and flavor) | Stable (no contamination of E. coli, fungi, and yeast was observed) |
Buontempo et al., 2010 [13] | Argentina | HPLC | Carvedilol tablet | 4, 25, and 40°C for 56 days | (i) Stable at all temperatures (>99%) | — | — |
Buontempo et al., 2013 [14] | Argentina | HPLC | Clobazam tablets | 4 and 25°C for 56 days | Stable (>98%) | Stable | — |
Casas et al., 2015 [15] | Spain | HPLC | Pure drug of enalapril and captopril | 5, 25, and 40°C for 90 days | (i) Stable only for 50 days at 50C | (i) Stable in consistency | — |
Freed et al., 2005 [16] | USA | HPLC | Accupril® tablets (quinapril) | −5°C for 28 days | Stable (≥90%) | — | — |
García et al., 2017 [17] | Argentina | UV-spectrophotometry | Benznidazole tablets | 5 and 25°C for 90 days | Stable (>99%) and no pH change | (i) No detectable changes in color, odour, and viscosity | Stable |
Han et al., 2006 [18] | UK | — | Tacrolimus pure drug | 22–26°C for 56 days | — | Stable | Stable |
Helin-Tanninen, 2010 [19] | Finland | HPLC | Nifedipine tablet | At 22°C and 6°C for 28 days | (i) Stable when protected from light, whereas on exposure to light, nifedipine degrades rapidly | — | — |
Juárez Olguín et al., 2008 [20] | Mexico | HPLC | Propafenone tablet | 15 ± 5°C and at refrigeration (3–5°C) for 90 days | Stable (>90%) | No color and odour change | Stable |
Klovrzová, 2016 [21] | Czech Republic | HPLC | Pure sotalol | Room temperature and in a refrigerator for 180 days | Stable (>95%) | — | Stable |
Klovrzová et al., 2013 [22] | Czech Republic | HPLC | Propranolol tablet | 5 ± 3°C and 25 ± 3°C for 180 days | Stable at both storage temperatures | — | Stable |
Kučerová et al., 2019 [23] | Czech Republic | Ultra-HPLC method with UV detection | Pure omeprazole drug | 4°C for 15 days | Stable | — | — |
Lafuente et al., 2019 [24] | Argentina | HPLC | Indomethacin injection | Room temperature for 17 days | Stable | Stable (no detectable changes in color, odour, and/or flavor) | Stable |
Lin et al., 2021 [25] | Taiwan | HPLC | Propafenone hydrochloride tablets | 2–8°C and room temperature for 90 days | Stable | Stable | Stable |
Mahmoud et al., 2014 [26] | Saudi | UV-spectrophotometer | Spironolactone tablets | Room temperature for 35 days | Stable (>90%) | Stable (no appearance change) | Stable |
Mendes et al., 2013 [27] | Brazil | HPLC | Furosemide, hydrochlorothiazide, and spironolactone tablets | 25 ± 2°C and 5 ± 3°C for 7 days | Stable, except hydrochlorothiazide | Stable | Stable |
Mohamed‐Ahmed et al., 2017 [28] | UK | Reverse phase HPLC and mass spectrometry | Pyridoxal 50-phosphate tablet | Room temperature for 24 hours | Stable at room temperature (protected from light) after 24 h, but unstable after 4 h when exposed to light. | — | — |
Pramann et al., 2016 [29] | USA | Ultra-performance liquid chromatography time-of-flight mass spectrometry | Aripiprazole tablet | 4°C for 91 days | Stable (>90%) | No apparent physical changes | — |
Provenza et al., 2014 [30] | Spain | Optical spectroscopy | Sildenafil tablet | 4 and 25°C for 90 days | Stable (>90%) | Stable at 25°C but problem of redispersibility at 4°C | Stable |
Shoosanglertwijit et al., 2011 [31] | Thailand | HPLC | Furosemide tablet | Glass bottles are protected from light and stored for 60 days at 4 ± 2°C room temperature (30 ± 2°C) and 3 controlled temperatures of 45°C | Stable (93%) | There was no significant alteration in the appearance (color and consistency) or odour of either formulation | Stable |
Soliman et al., 2014 [32] | Egypt | HPLC | Gabapentin tablet | Absence of light at 2–8°C in the refrigerator for 90 days | Stable | — | — |
Sosnowska et al., 2009 [33] | Poland | HPLC | Enalapril tablet | Absence of light at 4 and 25°C for 30 days | Stable (98%) | No appreciable changes from the initial pH and initial viscosities | — |
Van Der Vossen et al., 2016 [34] | Netherlands | HPLC-UV | Amlodipine tablet | 4°C, 25°C, and 40°C for 24 hours | At 25°C and 40°C, subsequent chemical degradation, but it is stable at 4 0C | Stable | — |
Zahálka et al., 2018 [35] | Czech Republic | HPLC | Furosemide | 25°C ± 3°C or at 40°C ± 0.5°C for 9 months | Stable (>90%) | No color, taste, and odour change | Stable |
Zaid, 2016 [36] | Palestine | UV-spectrophotometry | Paracetamol tablet | 25°C and 40°C for 4 months | Stable (>93%) | No change in organoleptic properties was observed | Stable |
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