Assessment of RP-HPLC Method Development and Validation for Simultaneous Estimation of Thymoquinone and Curcumin in Dosage Form| Chapter 14 | Challenges and Advances in Pharmaceutical Research Vol. 2

The goal of this research is to create and verify a simple, specific, accurate, and exact HPLC technique for concurrently measuring Curcumin (CUR) and Thymoquinone (THQ) in bulk and formulation, following ICH guidelines for analytical method development and validation.

Study Design: Using a C-18 Inertsil column and optimising factors, develop an RP-HPLC technique for quantifying Thymoquinone and Curcumin in bulk and formulation.

The current research was carried out in the year 2021 at Shri D. D. Vispute College of Pharmacy and Research Center, Panvel.

The RP-HPLC technique was developed employing an isocratic mobile phase of acetonitrile and water at a ratio of (82:18) v/v, with a flow rate of 0.9 mL/minute over an Inertsil ODS, 250 4.6 mm, 5 m column, at a column oven temperature of 30°C. A 256 nm photodiode array was used for detection.

The retention periods for curcumin and thymoquinone were 3.5 and 4.3 minutes, respectively. The technique displayed good linear response for thymoquinone and curcumin in concentration ranges of 4-18 g/ml and 10-45 g/ml, respectively, with correlation coefficient (R2) values of 0.999 for both. The highest permissible limit percentage of relative standard deviation for curcumin and thymoquinone studies was less than 2.0, i.e. 1.61 percent and 1.62 percent for curcumin and 0.47 percent and 0.42 percent for thymoquinone, respectively. The mean % recovery for both drugs was within acceptable limits. The devised and verified HPLC technique is simple, accurate, precise, and acceptable for analysis since all of the findings meet the acceptance criteria.

Conclusion: The new RP-HPLC technique at single wavelength was validated for system appropriateness, specificity, linearity, accuracy, precision, and robustness according to ICH requirements, and may be used for regular quality monitoring of medicines in pharmaceutical dosage forms. This approach may be used to analyse curcumin and thymoquinone samples together for routine quality control.

 

Author(s) Details:

Prajakta Jagtap,
Department of Quality Assurance, Shri. D. D. Vispute College of Pharmacy & Research Center, New Panvel - 410206, India.

Namrata Mahajan,
Department of Quality Assurance, Shri. D. D. Vispute College of Pharmacy & Research Center, New Panvel - 410206, India.

Anjali Parte,
Department of Quality Assurance, Shri. D. D. Vispute College of Pharmacy & Research Center, New Panvel - 410206, India.

Jeeja Pananchery,
Department of Pharmacognosy, Shri. D. D. Vispute College of Pharmacy & Research Center, Ne

Ashish Jain,
Department of Pharmacognosy, Shri. D. D. Vispute College of Pharmacy & Research Center, New Panvel - 410206, India.

Please see the link here: https://stm.bookpi.org/CAPR-V2/article/view/6586