Tuesday , 27 July 2021

Prospective Study Method Development and Validation of Gemictabine and Clarithromycin in Pure API and Combined Dosage Form by RP-HPLC

Sanju Srinivas1, Syed Mozhoruddin2
1Associate Professor Department of Pharmacy, Ganga Pharmacy College, Nizamabad, Telangana
2Department of Pharmaceutical Analysis, Ganga Pharmacy College, Nizamabad, Telangana

A new method was established for simultaneous estimation of  Gemcitabine and Clarithromycin, by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Gemcitabine and Clarithromycin, by using ZODIAC –SIL RP Agilent C18  (4.6 x 250mm, 5mm), Methanol: Sodium acetate buffer Ph 3 [70 : 30, v / v] with flow rate of 1.0 ml /min at 274nm.hosphate buffer (KH2PO4 and K2HPO4)   pH 9 ( pH was adjusted with orthophosphoric acid), detection wave length was 292 nm. The retention times were found to be 4.878 mins and 3.420 mins. The % purity of Gemcitabine and Clarithromycin, was found to be 100.27%  and  99.87%  respectively.  The  system  suitability parameters  for  Gemcitabine  and Clarithromycin, such as theoretical plates and tailing factor were found to be 3396, 1.4and 3696 and 1.4, the resolution was found to be 8.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Gemcitabine and Clarithromycin, was found in concentration range of 6.25µ g-37.5µ g and 0.5µ g-3.0µ g and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.27 and 0.40, % RSD for intermediate precision was 2.369 and 2.368 respectively. The precision study was precise, robust, and repeatable. LOD value was 2.456  and 4.312, and LOQ value was 0.032 and 0.1125 respectively.
Keywords: Agilent C18, Gemcitabine and Clarithromycin, RP-HPLC

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