Drug development and industrial pharmacy · 2026
An innovative RP-HPLC strategy for dual-drug analysis: simultaneous estimation of selegiline and biochanin A in bulk and SNEDDS.
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Tyagi Shivani, Trivedi Manisha, Kumar Jayendra
Аннотация
INTRODUCTION: This study aimed to develop and validate a rapid, accurate, and robust RP-HPLC method for the simultaneous quantification of Selegiline (SEL) and Biochanin A (BCA) in bulk and in self-nanoemulsifying drug delivery system (SNEDDS). Developing a validated analytical method for the novel SEL-BCA combination is important for ensuring precise quantification of the combination's potential applicability in Parkinson's disease (PD) management.
METHODS: Chromatographic separation was performed using an Agilent 1220 Infinity II HPLC system equipped with a 5TC-C18(2) column (250 × 4.6 mm, 5 µm) and a variable wavelength detector (VWD). An isocratic mode with mobile phase of acetonitrile (ACN) and water containing 0.1% o-phosphoric acid (50:50 v/v) was used at a flow rate of 1 mL min-1, with detection at isosbestic wavelength of 208 nm. Validation followed ICH Q2(R1) guidelines. SEL-BCA SNEDDS was formulated and characterized for particle size and PDI, and the validated method was applied to quantify in vitro drug release and % drug assay.
RESULTS: The method displayed excellent linearity over the 0.4-50 µg mL-1 concentration range, with correlation coefficients of 0.9997 for SEL and 0.9995 for BCA. System suitability parameters, including tailing factor < 1.5, resolution > 2, and theoretical plates > 2000, were satisfactory. The method remained robust despite small variations in flow rate, column temperature, injection volume, wavelength, and mobile phase composition. The developed SNEDDS presented a particle size of 120.3 nm and a PDI of 0.1925.
DISCUSSION: A simple, sensitive, and robust RP-HPLC method was successfully developed and validated for the concurrent estimation of SEL and BCA in bulk drug and SNEDDS.
METHODS: Chromatographic separation was performed using an Agilent 1220 Infinity II HPLC system equipped with a 5TC-C18(2) column (250 × 4.6 mm, 5 µm) and a variable wavelength detector (VWD). An isocratic mode with mobile phase of acetonitrile (ACN) and water containing 0.1% o-phosphoric acid (50:50 v/v) was used at a flow rate of 1 mL min-1, with detection at isosbestic wavelength of 208 nm. Validation followed ICH Q2(R1) guidelines. SEL-BCA SNEDDS was formulated and characterized for particle size and PDI, and the validated method was applied to quantify in vitro drug release and % drug assay.
RESULTS: The method displayed excellent linearity over the 0.4-50 µg mL-1 concentration range, with correlation coefficients of 0.9997 for SEL and 0.9995 for BCA. System suitability parameters, including tailing factor < 1.5, resolution > 2, and theoretical plates > 2000, were satisfactory. The method remained robust despite small variations in flow rate, column temperature, injection volume, wavelength, and mobile phase composition. The developed SNEDDS presented a particle size of 120.3 nm and a PDI of 0.1925.
DISCUSSION: A simple, sensitive, and robust RP-HPLC method was successfully developed and validated for the concurrent estimation of SEL and BCA in bulk drug and SNEDDS.