Volume No. :   8

Issue No. :  2

Year :  2018

ISSN Print :  2231-5667

ISSN Online :  2231-5675


Registration

Allready Registrered
Click to Login

RP-HPLC Method Development and Validation for the Estimation of Seratrodast in Bulk and Pharmaceutical Dosage Form



Address:   B. Sivagami1*, D. Nagendramma1, R. Chandrasekar2, Dr. M. Niranjan babu2
1Associate Professor, Department of Pharmaceutical Analysis, Seven Hills College of Pharmacy, Venkataramapuram, Tirupati, Chitoor Dist, 517561, A. P.
2Department of Pharmacognosy, Seven Hills College of Pharmacy, Venkataramapuram, Tirupati, Chitoor Dist, 517561, A. P.
*Corresponding Author
DOI No: 10.5958/2231-5675.2018.00019.4

ABSTRACT:
A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Seratrodast in Bulk and pharmaceutical dosage forms. The chromatographic separation of Seratrodast was achieved on a LC-1220 C 18 column with 100 x 4.6mm i.d. and 3.5µm particle size, using VW detection at 267?m. The optimized mobile phase was consisted of Methanol: Phosphate buffer (pH adjusted to 4 with Orthophosphoric acid) (70:30, v/v). The flow rate was 1ml/min and effluents were monitored at 267?m. Chromatogram showed the main peak at a retention time of 2.270min. The method was validated for linearity, accuracy, precision, and limit of detection, limit of quantification, robustness and ruggedness. The linearity was found in the concentration range of 10-150µg/ml. The Correlation coefficient was 0.999. The regression equation was found to be Y = 64890x + 18895. The limit of detection and limit of quantitation for estimation of Seratrodast was found to be 0.168µg/ml and 0.512µg/ml respectively. Recovery of Seratrodast was found to be in the range of 99.1-101.8%. Proposed method was successfully applied for the quantitative determination of Seratrodast in Bulk and Pharmaceutical dosage forms.
KEYWORDS:
Seratrodast, RP-HPLC, Method validation, ICH guidelines.
Cite:
B. Sivagami, D. Nagendramma, R. Chandrasekar, M. Niranjan babu. RP-HPLC Method Development and Validation for the Estimation of Seratrodast in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2018; 8(2): 96-102.
[View HTML]     



Visitor's No. :   80018