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Asian Journal of Pharmaceutical Analysis
Year : 2018, Volume : 8, Issue : 2
First page : ( 96) Last page : ( 102)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2018.00019.4

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

Sivagami B.1,*, Nagendramma D.1, Chandrasekar R.2, Dr. Babu M. Niranjan2

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 E-mail: sivagamib_27@rediffmail.com

Online published on 7 July, 2018.

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 267ηm. 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 267ηm. 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.

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Keywords

Seratrodast, RP-HPLC, Method validation, ICH guidelines.

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