Novel HPLC Analysis of Hydrocortisone in Conventional and Controlled-Release Pharmaceutical Preparations

Table 8

Characteristics and labelled strength of commercial hydrocortisone preparations analyzed using the developed HPLC method (DM) and the USP method.

Code	Dosage	Strength	Country of manufacture	Batch number	Date of manufacture	Expiry date	(%) (DM)	(%); (USP)
HP1	PFI	100 mg	Belgium	14HB24	04/2014	03/2017	98.41	98.60
HP2	PFI	100 mg	China	131255	12/2013	12/2016	102.60	102.34
HP3	PFI	100 mg	Belgium	14HB52	12/2014	11/2017	100.64	100.42
HP4	PFI	100 mg	India	5AB01007	10/2015	09/2018	101.20	101.27
HP5	PFI	100 mg	Belgium	15HB22	09/2015	08/2018	102.80	102.83
HP6	PF1	100 mg	India	5AE04010	10/2015	09/2018	100.63	100.35
HT1	Tablet	10 mg	China	150801	08/2015	08/2018	86.80	86.45
HT2	Tablet	10 mg	France	5EH3C	05/2015	05/2018	98.90	98.94
HT3	Tablet	5 mg	France	5ET4B	04/2014	04/2017	101.55	101.72
HT4	Tablet	10 mg	India	KC004	02/2014	02/2017	101.27	101.65
HT5	Tablet	5 mg	India	KD157	04/2015	04/2018	87.69	87.36
HT6	Tablet	5 mg	India	KD150	04/2015	04/2018	89.05	89.03
HT7	Tablet	10 mg	United Kingdom	13J11/C	10/2013	10/2016	94.38	94.27
HT8	Tablet	10 mg	United Kingdom	13J14/B	10/2013	10/2016	100.28	100.11
HT9	Tablet	10 mg	United Kingdom	13J12/A	08/2013	08/2016	98.22	98.09

= powder for injection (im/iv). criterion = 90–110%.