Development and validation of stability indicating RP-HPLC method for estimation of cyclandelate in bulk drug and capsule dosage form

Binit Patel, Archita Patel, Dilip Ghava, Rikeeta Padiya, Pravinkumar Darji

Xylopia Labs Private Limited, Ahmedabad, Gujarat, India

Refer this article

Binit Patel, Archita Patel, Dilip Ghava, Rikeeta Padiya, Pravinkumar Darji, 2023. Development and validation of stability indicating rp-hplc method for estimation of cyclandelate in bulk drug and capsule dosage form. Journal of medical pharmaceutical and allied sciences, V 12 - I 6, Pages - 6247 – 6253. Doi: https://doi.org/10.55522/jmpas.V12I6.5943.

ABSTRACT

For the quantification of Cyclandelate (CYL) in bulk medication and capsule dosage form in the presence of degradation products, a quick, accurate, and simple RP-HPLC method was devised. On the Phenomenex Luna C18 (250 mm x 4.6mm, 5 m) column, effective chromatographic separation was accomplished. The separation was made simple by employing the Isocratic elution program with Acetonitrile and buffer pH 3.0 (0.1% Triethylamine in water followed by pH correction with Trifluoroacetic acid) in the ratio of 70:30 (%v/v) at a flow rate of 1.2 mL/min, and an eluent was monitored at 220 nm. The degradation products were found to be isolated from the principal peak after being subjected to force degradation with acid, alkali, peroxide, thermal, and photolytic agents. The technique was linear in the range of 30-200 μg/mL, with a correlation coefficient of 0.9975. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 8.3 μg/mL and 25.1 μg/mL respectively. The presented method was validated for parameters such as system appropriateness, specificity, linearity, accuracy, precision, and robustness. The robustness investigation was part of the validation research as well. The outcomes for every metric are acceptable by ICH standards. Therefore, the method can be considered to be rapid and accurate for high-throughput analysis of this drug even when degradation products are present.

Keywords:

Validation, Stability Indicating, Degradation Product, Cyclandelate (CYL)

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