Implementation of QbD Strategies for HPLC Cleaning Method Development and Validation of Cinacalcet in API and Dosage Form

ABSTRACT

Background: Cinacalcet HCl is used to treat hyperthyroidism and hypercalcisim. QbD approach used to assess risk and develop cleaning method for Cinacalcet HCl. The Method Operable Design Region (MODR) was obtained by CCD concluded from surface and contour plot Analytical Target Profile defined with 15 variables verified for quality. Materials and Methods: The contour diagram displays the anticipated and optimized data, which includes the composition of the eluent phase consisting of potassium dihydrogen ortho Phosphate buffer with a pH of 3.5 and acetonitrile (CH3CN) in a ratio of 20:80 v/v. The flow rate was set at 1 mL/min for a duration of 10 min. The analysis was performed using a Kinetex C18 column at a temperature of 25ºC, and the wavelength chosen for detection was 279 nm. Results: After injecting swabbed samples from SS plate(10*10 cm), sharp and resolved peak of CIN at 2.8 min of retention was observed by a typical recuperation rate of 92.4% (±2.1%, n=3).The set method had a LOQ of 0.740 µg mL-1 and a LOD of 0.244 µg mL-1.The measured linearity of the calibration curve ranges from 0.25 to 12.5 gmL-1, with a r2 of 0.999. All validation parameter findings fell within the permitted range. % RSD of system suitability 0.03%, inter-day and intra-day precision % RSD value 1.07 and 0.95%, respectively, and accuracy (0.059-0.189%). Conclusion: QbD approach is applied effectively to optimize HPLC method for Cinacalcet estimation in formulation and API manufacturing.

KEYWORDS

• Cinacalcet
• Central Composite Design
• Modr
• Cleaning Method
• Analytical Target Profile
• Method Validation
• Qbd

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• DOI10.5530/ijper.20263117Copy

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