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Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The group"s operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India, the group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets.
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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF TADALAFIL AND DAPOXETINE HCL IN SOLID DOSAGE FORM
CHIRAG S. RAJPARA*1, JAWED AKHTAR1, AMIT KHANDHAR2
1. Department of Quality Assurance, School of Pharmaceutical Sciences, Jaipur National University, Jagatpura, Jaipur-302025, Rajasthan, India.
2. Zydus cadila pharma, moraiya,ahmedabad.
* A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for simultaneous estimation of Tadalafil and Dapoxetine HCL, Water Symmetry C-18 (150 x 4.6 mm),5 µ and a mobile phase composed of Buffer : Acetonitrile (65:35)
* The retention time of Tadalafil and Dapoxetine HCL were found to be10.08 and 4.45 min respectively. Linearity was established for Tadalafil and Dapoxetine HCL in the range of 8.0-60 μg/ml and 24.0-180.0 μg/ml respectively. The percentage recovery of Tadalafil and Dapoxetine HCL were found to be in the range of 99.7-100.6% and 98.07-99.09% respectively. The drug was subjected to acid and alkali hydrolysis, oxidation, dry heat and photolytic degradation. The degradation studies indicated, Tadalafil showed degradation in acid and alkali while it was found stable in H2O2, photolytic and in presence of dry heat and Dapoxetine showed degradation in thermal and peroxide while it was found stable in rest of parameters . The degradation products of Tadalafil and Dapoxetine HCL in acidic, alkaline conditions were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for the quantitative analysis of Tadalafil and Dapoxetine HCL in bulk drugs and formulations.
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Zydus Cadila is one of India's leading healthcare companies and a global healthcare provider with strengths all along the pharmaceutical value chain. The group's state-of-the-art manufacturing infrastructure is spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim. Of these, five facilities are USFDA approved. The group's formulation manufacturing hub at Moraiya, Ahmedabad has received approvals from the USFDA, MHRA of U.K., AFSSAPS of France, MCC of South Africa, ANVISA of Brazil to name a few.