Method operable design region for robust RP-HPLC analysis of pioglitazone hydrochloride and teneligliptin hydrobromide hydrate: incorporating hybrid principles of white analytical chemistry and design of experiments

Prajapati, Pintu; Rana, Bageshree; Pulusu, Veera Shakar; Shah, Shailesh

doi:10.1186/s43094-023-00546-5

Future Journal of Pharmaceutical Sciences

Table 6 Assessment of published and proposed RP-HPLC methods for estimation of THH and PIO using principles of white analytical chemistry, RGB model, NEMI, ESA, AGREE and GAPI tools

From: Method operable design region for robust RP-HPLC analysis of pioglitazone hydrochloride and teneligliptin hydrobromide hydrate: incorporating hybrid principles of white analytical chemistry and design of experiments

Principles of white analytical chemistry	Published RP-HPLC analysis of THH	Published RP-HPLC analysis of PIO	Proposed RP-HPLC analysis of PIO and THH
Red model-based assessment
R1 – Scope and application	Applied only for analysis of THH	Applied only for analysis of PIO	Applied for analysis of PIO and THH both
R2 – LOD and LOQ	Method was sensitive for estimation of THH	Method was sensitive for estimation of PIO	Method was sensitive for estimation of PIO and THH both
R3 – Precision	Method was precise for estimation of THH	Method was precise for estimation of PIO	Method was precise for estimation of PIO and THH both
R4 – Accuracy	Method was accurate for estimation of THH	Method was accurate for estimation of PIO	Method was accurate for estimation of THH and PIO both
Red-model score	80	80	100
Green model-based assessment
AGREE score	0.51	0.51	0.83
NEMI assessment	Acetonitrile is hazardous, corrosive and toxic organic solvent	Acetonitrile is hazardous, corrosive and toxic organic solvent	Ethanol is safe organic solvent and less hazardous to the environment
Eco-scale assessment	Total penalty points for method were found to be 12	Total penalty points for method were found to be 12	Total penalty points for method were found to be 6.0
GAPI assessment	E-factor was found to be 0.50	E-factor was found to be 0.50	E-factor was found to be 0.33
Green model score	51	51	80
Blue model-based assessment
B1 – Cost efficiency	Only THH sample was analyzed	Only PIO sample was analyzed	Both PIO and THH sample was analyzed
B2 – Time efficiency	THH sample was analyzed with run time of 10 min	PIO sample was analyzed with run time of 10 min	Both THH and PIO sample was analyzed with 5.0 min run time
B3 – Requirements	Require less than 3 steps for analysis	Require less than 3 steps for analysis	Require less than 3 steps for analysis
B4 – Operational simplicity	Skilled person requires for analysis	Skilled person requires for analysis	Skilled person requires for analysis
Blue model score	80	80	100
White analytical chemistry (WAC)-based assessment
Average of Red, Green and Blue model scores	Average of (80 + 51 + 80) = 70.33	Average of (80 + 51 + 80) = 70.33	Average of (100 + 80 + 100) = 93.33
WAC status	Acceptable white	Acceptable white	Excellent white

THH Teneligliptin hydrobromide hydrate, PIO Pioglitazone hydrochloride, AGREE Analytical GREEnness, GAPI Green analytical procedure index, NEMI National environmental method index, WAC score: Poor white (0 to 25), Average white (26 to 50), Acceptable white (51 to 75), Excellent white (76 to 100)

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