Analytical Method Development and Validation For in Vinblastine and Vincristine Combine Dosage Forms by RP–HPLC Method

K.Nithiyananthan^1*, K.V.S.Prasadarao^2
1Research Scholar, Acharya Nagarjuna University, Guntur, Andhra Pradesh 522510.
²Principal, Rahul Institute of Pharmaceutical Science And Research, Chirala, Andhra Pradesh 523157.

A B S T R A C T
The chromatographic conditions were successfully developed for the separation of Vinblastine and Vincristine by using XterraC185µm (4.6*250mm) column, flow rate was1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wavelength was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module2695, PDA Detector 996, Empower-software version-2. The retention times were found to be 2.399mins and 3.907mins.  The %purity of Vinblastine and Vincristine   wasfoundtobe100.7%and 101.4% respectively. The system suitability parameters for Vinblastine and Vincristine   such as theoretical plates and tailing factor were found to be 1.3, 5117.5 and 1.4, 3877.3 the resolution was found to be 8.0. The analytical method was validated according to ICH guidelines (ICH, Q2(R1)). The linearity study for Vinblastine and Vincristine was found in the concentration range of  1μg-5μg  and  100μg-500μg   and correlation coefficient(r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 0.2and0.4,%RSDfor intermediate precision was 0.5and 0.1 respectively. The precision study was precise, robust, and repeatable. LOD value was 2.95and 3.04, and LOQ value was 9.87 and 10 respectively.
Keywords: Vinblastine and Vincristine, Empower-software, ICH etc.