1. Stability Indicating Simultaneous RP-HPLC Method for the estimation of Metformin Hydrochloride and Nateglinide in Bulk.
- Author
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Farhana, Jabeen, Gautam, Suresh Kumar, Bharkatiya, Meenakshi, Kurella, Kiran Kumar, Sharma, Komal, Khandelwal, Manisha, Chakraborthy, Gunosindhu, Ranjan, Rajeev, and Jaiswal, Reema
- Subjects
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HIGH performance liquid chromatography , *METFORMIN , *ACETONITRILE , *ORTHOPHOSPHATES , *PHOTODEGRADATION - Abstract
A new stability-indicating RP-HPLC method for the determination of metformin hydrochloride and nateglinidein bulk was developed. The separation wasperformed on a Hypersil BDS-C18column (250 X 4.6 mm ID, 5 µm) by using 0.05 M potassium dihydrogen orthophosphate (pH 3.5) acetonitrile (30:70 v/v) as the mobile phase with UV detection at 226 nm. Under these chromatographic conditions, favorable retention parameters were obtained with good symmetry of peaks for the studied compounds. The validation studies performed as per ICH guidelines. The proposed method showed high degree of accuracy, and precision, with a good degree of sensitivity and robustness. The drugs were subjected to forced degradation using acidic, alkaline, oxidation, wet heat, dry heat, and photodegradation conditions. The results confirmed that the method could effectively separate the drugs in the presence of their degradation products, hence it can be regarded as stability indicating. [ABSTRACT FROM AUTHOR]
- Published
- 2023