Smart Spectrophotometric Methods for Concurrent Determination of Furosemide and Spironolactone Mixture in Their Pharmaceutical Dosage Forms

Lotfy, Hayam M.; El-Hanboushy, Sara; Fayz, Yassmin M.; Abdelkawy, Mohammed

doi:10.1590/s2175-97902022e19487

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Brazilian Journal of Pharmaceutical Sciences

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Article • Braz. J. Pharm. Sci. 58 • 2022 • https://doi.org/10.1590/s2175-97902022e19487 copy

Smart Spectrophotometric Methods for Concurrent Determination of Furosemide and Spironolactone Mixture in Their Pharmaceutical Dosage Forms

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Simple, precise, accurate and speciﬁc spectrophotometric methods are progressed and validated for concurrent analysis of Furosemide (FUR) and Spironolactone (SPR) in their combined dosage form depend on spectral analysis procedures. Furosemide (FUR) in the binary mixture could be analyzed at its λ_{max 274} nm using its recovered zero order absorption spectrum using constant multiplication method (CM). Spironolactone (SPR) in the mixture could be analyzed at its λ_max 238 nm by ratio subtraction method (RS). Concurrent determination for FUR and SPR in their mixture could be applied by amplitude modulation method (AM), absorbance subtraction method (AS) and ratio difference (RD). Linearity ranges of FUR and SPR were (2.0µg/mL-22.0 µg/mL) and (3.0µg/mL-30.0 µg/mL), respectively. Specificity of the proposed spectrophotometric methods was examined by analyzing the prepared mixtures in laboratory and was applied successfully for pharmaceutical dosage form analysis which have the cited drugs without additives contribution. The proposed spectrophotometric methods were also validated as per as the guidelines of ICH. Statistical comparison was performed between the obtained results with those from the official methods of the cited drugs, using one-way ANOVA, F-test and student t-test. The results are exhibiting insignificant difference concerning precision and accuracy.

Keywords:
Absorbance subtraction method (AS); Amplitude modulation method (AM); Ratio subtraction method (RS); Constant multiplication method (CM); Ratio difference method (RD)

Drug name	FUR		SPR
Methods	D⁰ (274 nm)	RD	D⁰ (238 nm)	RD	AM at (254.8 nm)	AS
Range^a (µg/mL)	2.00-22.00		3.00-30.00		3.00-22.00
Regressions Parameters
Slope	0.0666	0.1217	0.0470	0.0804	0.9996	0.0218
intercept	0.0064	0.0603	0.0219	0.0418	0.0393	0.0002
Correlation coefficient: (r)	1.0000	0.9999	0.9999	0.9999	1.0000	0.9999
Accuracy (Mean±SD)	99.75±0.44	99.26±1.05	100.07±0.28	99.66±1.00	99.31±1.08	100.04±0.60
Precision
Repeatability^b	99.84±0.463	100.41±0.644	100.25±0.697	100.21±0.980	99.97±0.068	100.24±0.890
Inter-day precision^c	100.24±0.697	100.01±1.044	100.16±1.030	99.38±1.199	100.00±0.138	99.63±0.917
Robustness (%RSD^d)	0.756	0.983	0.956	0.791	0.882	0.855

%Recovery^a±SD
FUR: SPR		FUR				SPR
Ratio	Concentrations (µg/mL)	CM	RD	AM	AS	RS	RD	AM	AS
(1:2.5)^*	3:7.5	99.02	100.00	99.79	99.44	99.93	99.76	101.47	99.91
(1:5)^*	3:15	100.00	100.17	99.86	100.10	100.00	99.71	100.19	99.98
(1:3)	4:12	100.57	100.00	100.02	99.43	100.13	99.93	100.59	100.16
(2:3.6)	5:9	100.47	100.28	99.82	99.85	99.86	100.49	100.35	100.02
(1:6)	3:18	99.42	99.91	98.96	100.10	100.39	100.23	99.46	99.66
Mean±SD		99.90±0.67	100.07±0.15	99.69±0.42	99.78±0.33	100.06±0.21	100.02±0.33	100.41±0.73	99.95±0.18

	FUR				SPR
	CM	RD	AM	AS	RS	RD	AM	AS
Pharmaceutical dosage form ^a (found%±SD):	99.70±0.36	99.78±0.42	100.52±0.37	98.94±0.32	100.44±0.34	98.58±0.42	99.51±0.37	100.30±0.32
D.F (1:2.5)	99.70±0.36	99.78±0.42	100.52±0.37	98.94±0.32	100.44±0.34	98.58±0.42	99.51±0.37	100.30±0.32
D.F (1:5)	98.97±0.31	100.51±0.39	99.21±0.38	99.86±0.31	100.43±0.49	99.45±0.39	100.00±0.41	101.07±0.41
Standard Addition ^b (Recovery%±SD):	100.19±0.17	100.09±0.16	99.95±0.16	99.37±0.63	100.00±0.49	99.90±0.72	100.02±0.49	100.14±0.57
D.F (1:2.5)^c	100.19±0.17	100.09±0.16	99.95±0.16	99.37±0.63	100.00±0.49	99.90±0.72	100.02±0.49	100.14±0.57
D.F (1:5)^d	100.12±0.21	100.28±0.13	99.68±0.67	99.76±0.24	100.13±0.27	99.95±0.36	99.88±0.36	99.79±0.19

Parameters	FUR			SPR
Parameters	D⁰ (274 nm)	RD (ΔP_270-260nm)	Official method (Pharmacopoeia, 2007Pharmacopoeia B. The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), London, United Kingdom. 2007;6.)^a	D⁰ (238 nm)	RD (ΔP_249-238nm)	AM at (254.8 nm)	AS	Official method (Pharmacopoeia, 2002Pharmacopoeia E. European pharmacopoeia. Strasbourg: Council of Europe. 2002.)
Mean	99.93	100.23	99.90	99.84	99.80	99.92	100.09	99.87
SD	0.54	0.88	0.61	0.78	0.98	0.32	1.05	0.60
n	6	6	6	7	7	7	7	6
Variance	0.2916	0.7744	0.3721	0.6084	0.9604	0.1024	1.1025	0.3600
Student’s t-test	0.090 (2.228)	0.755 (2.228)		0.077 (2.201)	0.273 (2.201)	0.192 (2.201)	0.452 (2.201)
F test	1.28 (5.05)	2.08 (5.05)		1.69 (4.95)	2.67 (4.95)	3.52 (4.39)	3.06 (4.95)

Source of variation	Sum of squares	DF	Mean Square	F value	P value	F crit
FUR
Between exp.	1.208779	2	0.402926	1.005032	0.411089	3.098391
Within exp.	8.018183	15	0.400909
Total	9.226963	17
SP
Between exp.	0.359199	4	0.0898	0.140694	0.965665	2.701399
Within exp.	18.50957	29	0.638261
Total	18.86877	33

Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Av. Prof. Lineu Prestes, n. 580, 05508-000 S. Paulo/SP Brasil, Tel.: (55 11) 3091-3824 - São Paulo - SP - Brazil
E-mail: bjps@usp.br

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[1] *Correspondence: S. El-Hanboushy. Assistant Lecturer of Pharmaceutical Chemistry. Department of Pharmaceutical Chemistry. Faculty of Pharmacutical sciences and pharmaceutical industries. Future University in Egypt. End of 90^th, Road 50^th Settlement, New Cairo, 11865, Cairo, Egypt. Phone: +201002441323. Fax: +(202) 26186111. Email: sara.rasheed@fue.edu.eg