A Validated HPLC Method using C18 Analytical Column (Agilent) for the Estimation of Cyclobenzaprine Hydrochloride by Quality by Design Approach in Bulk and Its Tablet Dosage Form

Deepak D. Pokharkar *

NCRD's Sterling Institute of Pharmacy, Plot No. 93/93A, Sector - 19, Nerul (E), Seawoods, Navi Mumbai, Maharashtra 400706, India.

Raghavdeep Sharma

NCRD's Sterling Institute of Pharmacy, Plot No. 93/93A, Sector - 19, Nerul (E), Seawoods, Navi Mumbai, Maharashtra 400706, India.

Shreelekha N. Desai

NCRD's Sterling Institute of Pharmacy, Plot No. 93/93A, Sector - 19, Nerul (E), Seawoods, Navi Mumbai, Maharashtra 400706, India.

Lekha Dhake

NCRD's Sterling Institute of Pharmacy, Plot No. 93/93A, Sector - 19, Nerul (E), Seawoods, Navi Mumbai, Maharashtra 400706, India.

*Author to whom correspondence should be addressed.


Abstract

Cyclobenzaprine hydrochloride is used to treat muscle spasms brought on by acute, uncomfortable musculoskeletal diseases. The primary objective of this work is to develop accurate, quick and precise HPLC method for Cyclobenzaprine hydrochloride. The method used is a Central Composite Design to get exact data for the procedure. Various parameters were used to validate and to develop method. The optimized model for the analysis of  Cyclobenzaprine Hydrochloride was found to have an area 8.3239. This optimization was done on the  C18 analytical column(Agilent) with mobile phase as methanol: 0.01 % Orthophosphoric acid (61:39 v/v) and a flow rate maintain was 0.9 ml/min with a detection wavelength of 224 nm. With the use of a correlation coefficient (r2=0.999), the linearity of Cyclobenzaprine hydrochloride in the 5–25 ug/ml range was determined. The accuracy values were discovered to fall between 99.86 and 100.71%. While the robustness was shown to be less than 0.06 for flow rate and for wavelength was 0.09 % RSD, also the intraday and interday precision were determined to be under 0.28 and 0.29 % RSD. The most effective approach for analysing Cyclobenzaprine hydrochloride is the one that has been presented. The development and validation of the HPLC technique for Cyclobenzaprine hydrochloride were assessed.

Keywords: Cyclobenzaprine hydrochloride, HPLC method, validation, central composite design, quality by design


How to Cite

Pokharkar, D. D., Sharma, R., Desai, S. N., & Dhake, L. (2024). A Validated HPLC Method using C18 Analytical Column (Agilent) for the Estimation of Cyclobenzaprine Hydrochloride by Quality by Design Approach in Bulk and Its Tablet Dosage Form. Asian Journal of Chemical Sciences, 14(1), 50–57. https://doi.org/10.9734/ajocs/2024/v14i1285

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