Wednesday , 21 October 2020

Analytical Method Development and Validation for Simultaneous Estimation of Indacaterol and Glycopyrrolate in Pharmaceutical Dosage Forms by RP-HPLC

P. Devika1, P. Sowjanya2, Gampa Vijay Kumar3*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
3Professor and Head, Dept.of Pharmacy, KGR InstituteofTechnology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

ABSTRACT
A new method was established for simultaneous estimation of Indacaterol and Glycopyrrolate by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Indacaterol and Glycopyrrolate by using Xterra C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN   (55:45%v/v)   (pH   was   adjusted   with   orthophosphoric   acid), detection wave length was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2.The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Indacaterol and Glycopyrrolate was found   in   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 was0.7 and 0.4, % RSD for intermediate precision was 0.18 and 0.39 respectively.
Keywords: Indacaterol, Glycopyrrolate, RP-HPLC, validation.

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