DOI: 10.21276/ajptr
Sat, 25 May 2019

Forced Degradation and Stability Indicating Method Development and Validation of Ratinovir by RP-HPLC In Bulk and Pharmaceutical Dosage Form

Merugu Manasa*1, P. Siva Kumar1, N. Sahani1, N.Sujatha1, P.Sahithi1

1.Department of Pharmaceutical Analysis, Pulla Reddy Institute of Pharmacy, Domadugu(V), Guumadidala(M),Sangareddy(D)


A stable, simple, accurate, precise, robust and highly selective Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed and validated using ritonavir. Chromatographic separation was achieved using cyber labs, LC 100 separation module, Agilent C18 column at temperature 30°C. Flow rate selected was 1ml/min. Both drugs are identified with UV detector at 256nm. Mobile phase employed was Methanol: Water (50:50), which resulted best   sensitivity. Developed method was validated in terms of linearity, range (25-150µg/ml), precession (correlation coefficient is less than 0.999), robustness, accuracy(recovery was 101.96%) and  under stress conditions drug degradation was less than 10%.The validation of proposed stability indicating method was verified by recovery studies and can be applicable in routine pharmaceutical analysis.

Keywords: RP-HPLC, methanol, HPLC grade water, stress studies, stability, method development, validation

[PDF]   Viewed: 402   Downloaded: 63 DOI No: 10.21276/ajptr.2018.08.02.15
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