Applying green analytical chemistry for development and validation of RP-HPLC stability indicating assay method for estimation of fenoverine in bulk and dosage form using quality by design approach

ABSTRACT

A green and robust reverse-phase liquid chromatographic method has been developed for the determination of fenoverine (FEN), by applying combined principles of green analytical chemistry and quality by design approaches on a Spherisorb C18 column (150 × 4.6 mm, 3 µm) with UV detection at 262 nm. A two level fractional factorial design (2^^7-3) Res IV was used for screening of influential chromatographic factors. The critical method parameters actively affecting critical quality attributes (CQAs) were identified and further optimized using Box–Behnken design. The predicted optimum assay conditions comprised of methanol and ammonium acetate buffer 20 mM, in an extent of 81:19% v/v individually having a flow rate of 1.0 mL/min with a column oven temperature of 33°C. The drug was stressed in hydrolytic, oxidative, reductive, thermal, and photolytic conditions. The developed method was validated successfully. The detector response was linear in the concentration of 0.5–160 µg/mL with a limit of detection (LOD) and limit of quantitation (LOQ) as 0.1 and 0.3 µg/mL, respectively. The % recovery was found to be 99.7%. The analytical method volume intensity value for developed method was 45 mL and the environment assessment tool (EAT) score was 41.07. The method is simple, environmentally benign, rapid, and robust for the determination of FEN in bulk and in its dosage form.

GRAPHICAL ABSTRACT

KEYWORDS:

• Analytical method volume intensity (AMVI)
• green analytical chemistry (GAC)
• high-performance liquid chromatography environment assessment tool (HPLC-EAT)
• quality by design (QbD)
• reverse phase-high performance liquid chromatography (RP-HPLC)
• stability-indicating assay method (SIAM)

Acknowledgments

The authors are thankful to Micro Labs Limited (Bengaluru, India), for providing pharmaceutical-grade FEN drug as a gift sample. They are also thankful to Ministry of Chemical and Fertilizers, Govt. of India for financially supporting the research and Dr. Kiran Kalia, Director NIPER-Ahmedabad for constant support, motivation, and providing infrastructure and facilities for performing the research work. The entire research work was performed and manuscript was drafted by Seema Saroj under the most valuable guidance and thorough support of Dr. Vinod Jairaj and Ms. Rajeshwari Rathod.

Declaration of interests

The authors declare that they have no competing interests.